【海外法规速递】FDA新增1003种II类医疗器械的上市前通告豁免
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基于产品能够满足安全有效的原则，FDA新增1003种器械可以豁免上市前通告(Exempt from 510(k) premarket notification)的要求。根据[21世纪治愈法案]已于今年3月发布了草案，旨在减轻法规负担和降低企业成本。
然而豁免510(k)并非意味着其他法规要求也得到豁免，除非有相关的法规条令明确提出可以豁免，例如GMP生产要求，包装和标签以及列名的要求等。
正在受理中的510(k)若在此次豁免目录中，则需要与FDA做进一步沟通以确认豁免规则是否适用于该器械，否则该510(k)的申请需要继续进行下去。
申请方已具有510(k)的器械，而该器械又符合此次豁免要求，则不需要采取任何行动，若该器械只是部分符合豁免要求，则需要进一步明确该特定器械最终豁免与否。
同时，FDA针对部分豁免的器械新增了产品代码，申请方需要评估是继续沿用原先代码还是改为新增的代码，以及衍生而来的列名相关事项也需引起关注。
以下为此次新增的II类器械豁免510(k)要求的目录：
21 CFR section | Device type | Product code |
862.1020 | Acid Phosphatase, Nitrophenylphosphate. | CJN |
862.1020 | Acid Phosphatase, Thymol Blue Monophosphate. | CJR |
862.1020 | Acid Phosphatase, Disodium Phenylphosphate. | CJX |
862.1020 | Acid Phosphatase, Naphthyl Phosphate | CKB |
862.1020 | Acid Phosphatase, Thymolphthale Inmonophosphate. | CKE |
862.1020 | Acid Phosphatase, Beta Glycerophosphate | CKH |
862.1020 | Acid Phosphatase (Prostatic), Tartrate Inhibited | JFH |
862.1090 | Radioassay, Angiotensin Converting Enzyme. | KQN |
862.1100 | Vanillin Pyruvate, AST/SGOT | CIF |
862.1100 | Diazo, AST/SGOT | CIQ |
862.1100 | Hydrazone Colorimetry, AST/SGOT | CIS |
862.1100 | NADH Oxidation/NAD Reduction, AST/SGOT. | CIT |
862.1150 | Calibrator, Primary | JIS |
862.1150 | Calibrator, Secondary | JIT |
862.1150 | Calibrator, Surrogate | JIW |
862.1150 | Calibrator, Multi-Analyte Mixture | JIX |
862.1345 | Drink, Glucose Tolerance | MRV |
862.1350 | Continuous Glucose Monitor Secondary Display. | PJT |
862.1445 | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes. | CEX |
862.1445 | Electrophoretic, Lactate Dehydrogenase Isoenzymes | CFE |
862.1445 | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes | JGF |
862.1509 | System, Test, Urinary Methylmalonic Acid | LPT |
862.1685 | Radioimmunoassay, Thyroxine-Binding Globulin. | CEE |
862.1700 | Radioimmunoassay, Total Thyroxine | CDX |
862.1700 | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine. | KLI |
862.2265 | High Throughput DNA Sequence Analyzer. | PFF |
862.2570 | Instrumentation For Clinical Multiplex Test Systems. | NSU |
862.2570 | Real Time Nucleic Acid Amplification System. | OOI |
862.2570 | Mass Spectrometer For Clinical Multiplex Test Systems | OTA |
862.2570 | Micro Total Analysis Instrument System. | OUE |
862.2570 | Complete Gene Expression Profiling Accessory Reagents | OVA |
862.2570 | DNA Genetic Analyzer | PCA |
862.2570 | Data Acquisition Software | PQQ |
862.3100 | Enzyme Immunoassay, Amphetamine. | DKZ |
862.3100 | Radioimmunoassay, Amphetamine | DJP |
862.3100 | Thin Layer Chromatography, Amphetamine. | DIT |
862.3100 | Gas Chromatography, Amphetamine | DOD |
862.3100 | Liquid Chromatography, Amphetamine. | DNI |
862.3150 | Enzyme Immunoassay, Barbiturate | DJL |
862.3150 | Enzyme Immunoassay, Barbiturate | DIS |
862.3150 | Radioimmunoassay, Barbiturate | DKN |
862.3150 | Thin Layer Chromatography, Barbiturate. | DKX |
862.3150 | Mercury Dithiazone, Colorimetry, Barbiturate. | DJN |
862.3150 | Hemagglutination Inhibition, Barbiturate. | DLX |
862.3150 | Gas Liquid Chromatography, Barbiturate. | DMF |
862.3150 | High Pressure Liquid Chromatography, Barbiturate | KZY |
862.3170 | Enzyme Immunoassay, Benzodiazepine | JXM |
862.3170 | High Pressure Liquid Chromatography, Benzodiazepine. | LAA |
862.3170 | Test, Benzodiazepine, Over The Counter | NFV |
862.3170 | Gas Chromatography, Benzodiazepine. | KZZ |
862.3170 | Thin Layer Chromatography, Benzodiazepine. | LAB |
862.3200 | Calibrators, Drug Mixture | DKB |
862.3200 | Calibrators, Drug Specific | DLJ |
862.3200 | Calibrators, Ethyl Alcohol | DNN |
862.3250 | Enzyme Immunoassay, Cocaine and Cocaine Metabolites | DIO |
862.3250 | Radioimmunoassay, Cocaine Metabolite. | KLN |
862.3250 | Enzyme Immunoassay, Cocaine | JXO |
862.3250 | Hemagglutination, Cocaine Metabolites (Benzoylecgonine). | DLN |
862.3250 | Thin Layer Chromatography, Cocaine. | DMN |
862.3250 | Free Radical Assay, Cocaine | DIR |
862.3250 | Gas Chromatography, Cocaine | DIN |
862.3250 | Thin Layer Chromatography, Benzoylecgonine. | DOM |
862.3250 | High Pressure Liquid Chromatography, Cocaine and Cocaine Metabolites | LAC |
862.3270 | High Pressure Liquid Chromatography, Codeine. | LAE |
862.3270 | Thin Layer Chromatography, Codeine. | DLD |
862.3270 | Gas Chromatography, Codeine | LAD |
862.3580 | Radioimmunoassay, LSD (125–I) | DLB |
862.3580 | Free Radical Assay, LSD | DOL |
862.3610 | Gas Chromatography, Methamphetamine | LAF |
862.3610 | Thin Layer Chromatography, Methamphetamine. | DJC |
862.3610 | High Pressure Liquid Chromatography, Methamphetamine | LAG |
862.3610 | Test, Methamphetamine, Over The Counter. | NGG |
862.3620 | Enzyme Immunoassay, Methadone | DJR |
862.3620 | Hemagglutination Inhibition, Methadone. | DIW |
862.3620 | Gas Chromatography, Methadone | DMB |
862.3620 | Thin Layer Chromatography, Methadone. | DKR |
862.3620 | Liquid Chromatography, Methadone | DNT |
862.3620 | Free Radical Assay, Methadone | DPP |
862.3630 | Radioimmunoassay, Methaqualone | KXS |
862.3640 | Thin Layer Chromatography, Morphine. | DNK |
862.3640 | Radioimmunoassay, Morphine (123–I), Goat Antibody Ammonium Sulfate Sep. | DOE |
862.3640 | Fluorometry, Morphine | DJJ |
862.3640 | Liquid Chromatography, Morphine | DPK |
862.3640 | Gas Chromatography, Morphine | DMY |
862.3640 | Hemagglutination Inhibition, Morphine. | DLR |
862.3640 | Free Radical Assay, Morphine | DOK |
862.3640 | Radioimmunoassay, Morphine (3–H), Goat Antibody Ammonium Sulfate Sep. | DIQ |
862.3640 | Radioimmunoassay, Morphine-Barbiturate (125–I), Goat Antibody. | DNA |
862.3650 | Enzyme Immunoassay, Opiates | DJG |
862.3650 | Gas Chromatography, Opiates | DJF |
862.3650 | Hemagglutination, Opiates | DLT |
862.3650 | Thin Layer Chromatography, Opiates | LAI |
862.3650 | Free Radical Assay, Opiates | DKT |
862.3650 | High Pressure Liquid Chromatography, Opiates | LAH |
862.3700 | Enzyme Immunoassay, Propoxyphene. | JXN |
862.3700 | Thin Layer Chromatography, Propoxyphene | DPN |
862.3700 | Gas Chromatography, Propoxyphene | LAJ |
862.3700 | High Pressure Liquid Chromatography, Propoxyphene | LAK |
862.3870 | Enzyme Immunoassay, Cannabinoids. | LDJ |
862.3870 | Reagents, Test, Tetrahydrocannabinol. | DKE |
862.3870 | Radioimmunoassay, Cannabinoid(S) | LAT |
862.3910 | High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs. | LFI |
862.3910 | U.V. Spectrometry, Tricyclic Antidepressant Drugs. | LFH |
862.3910 | Thin Layer Chromatography, Tricyclic Antidepressant Drugs. | MLK |
864.5400 | Fibrometer | GIE |
864.5400 | Timer, Coagulation | JBT |
864.5425 | Control, Plasma, Abnormal | GGC |
864.5425 | Plasma, Coagulation Control | GGN |
864.5425 | Plasma, Control, Normal | GIZ |
864.6550 | Control, Fecal Occult Blood | OSL |
864.6650 | Study, Platelet Adhesive | JBZ |
864.7275 | Test, Euglobulin Lysis | JBO |
864.7300 | Fibrin Monomer Paracoagulation | JBN |
864.7340 | Fibrinogen Standard | GFX |
864.7340 | Plasma, Fibrinogen Control | GIL |
864.7375 | Glutathione, Red-Cell | GII |
864.7375 | Fluorescence, Visual Observation (Qual., U.V.), Glutathione Reductase. | JMH |
864.7375 | Assay, Glutathione Reductase | KQF |
864.7415 | Control, Hemoglobin, Abnormal | JCM |
864.7455 | Stain, Fetal Hemoglobin | GHQ |
864.7500 | Acid Hematin | GGF |
864.7720 | Test, Prothrombin Consumption | GGQ |
864.7735 | Prothrombin-Proconvertin and Thrombotest | JPF |
864.8150 | Calibrator for Cell Indices | KRX |
864.8165 | Calibrator for Hemoglobin and Hematocrit Measurement | KRZ |
864.8175 | Calibrator for Platelet Counting | KRY |
864.8185 | Calibrator for Red-Cell and White-Cell Counting | KSA |
864.8625 | Standards and Controls, Hemoglobin, Normal and Abnormal. | GFS |
864.8625 | Control, White-Cell | GGL |
864.8625 | Control, Hemoglobin | GGM |
864.8625 | Control, Platelet | GJP |
864.8625 | Control, Red-Cell | GJR |
864.8625 | Control, Hematocrit | GLK |
864.8625 | Mixture, Control, White-Cell and Red-Cell Indices. | GLQ |
864.8625 | Control, Cell Counter, Normal and Abnormal. | JCN |
864.8625 | Mixture, Hematology Quality Control | JPK |
864.8625 | Material, Quality Control, Semen Analysis | NRF |
864.8625 | Control Material, Blood Circulating Epithelial Cancer Cell. | NRS |
864.9400 | Solution, Stabilized Enzyme | KSK |
866.3395 | Norovirus Serological Reagents | OUC |
866.5210 | Immunochemical, Ceruloplasmin | CHN |
866.5210 | Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control. | DCT |
866.5210 | Ceruloplasmin, FITC, Antigen, Antiserum, Control | DCY |
866.5210 | Ceruloplasmin, Antigen, Antiserum, Control. | DDB |
866.5210 | P-Phenyl-Enediamine/EDTA (Spectrophotometric), Ceruloplasmin. | JFQ |
866.5210 | Indirect Copper Assay, Ceruloplasmin. | JFR |
866.5470 | Hemoglobin, Chain Specific, Antigen, Antiserum, Control | DAM |
866.5620 | Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control. | DDT |
866.5620 | Alpha-2-Macroglobulin, FITC, Antigen, Antiserum, Control | DDY |
866.5620 | Alpha-2-Macroglobulin, Antigen, Antiserum, Control. | DEB |
866.5630 | System, Test, Beta-2-Microglobulin Immunological | JZG |
866.5750 | System, Test, Radioallergosorbent (RAST) Immunological. | DHB |
866.5910 | Quality Control Material, Genetics, DNA. | NZB |
868.1040 | Algesimeter, Powered | BSI |
868.1400 | Legging, Compression, Non-Inflatable. | LLK |
868.2385 | Analyzer, Nitrogen Dioxide | MRQ |
868.2500 | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | KLK |
868.2500 | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia. | LPP |
868.2550 | Pneumotachometer | JAX |
868.5180 | Bed, Rocking, Breathing Assist | CCO |
868.6250 | Compressor, Air, Portable | BTI |
870.1330 | Wire, Guide, Catheter | DQX |
870.1390 | Trocar | DRC |
870.1650 | Syringe, Balloon Inflation | MAV |
870.1875 | Lung Sound Monitor | OCR |
870.2675 | Oscillometer | DRZ |
870.2770 | Analyzer, Body Composition | MNW |
870.4280 | Filter, Prebypass, Cardiopulmonary Bypass. | KRJ |
870.4290 | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL |
870.4340 | Monitor and/or Control, Level Sensing, Cardiopulmonary Bypass. | DTW |
870.4400 | Reservoir, Blood, Cardiopulmonary Bypass. | DTN |
870.4420 | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | DTS |
870.4430 | Suction Control, Intracardiac, Cardiopulmonary Bypass | DWD |
872.1720 | Tester, Pulp | EAT |
872.3260 | External Cleaning Solution | PME |
872.3300 | Coating, Denture Hydrophilic, Resin | EBE |
872.3540 | Pad, Denture, Over The Counter | EHR |
872.3540 | Cushion, Denture, Over The Counter | EHS |
872.3560 | Reliner, Denture, Over The Counter | EBP |
872.3590 | Denture, Plastic, Tooth | ELM |
872.3600 | Denture Preformed (Partially Prefabricated Denture). | EKO |
872.3890 | Splint, Endodontic Stabilizing | ELS |
872.5550 | Ring, Teething, Fluid-Filled | KKO |
872.6770 | Syringe, Cartridge | EJI |
874.1090 | Tester, Auditory Impedance | ETY |
874.1090 | Tympanometer | NAS |
874.1120 | Generator, Electronic Noise (for Audiometric Testing). | ETS |
874.1325 | Electroglottograph | KLX |
874.3310 | Calibrator, Hearing Aid/Earphone and Analysis Systems | ETW |
874.3320 | Hearing Aid, Group and Auditory Trainer. | EPF |
874.3320 | Device, Assistive Listening | LZI |
874.3330 | Hearing Aid, Master | KHL |
874.3430 | Mold, Middle-Ear | ETC |
874.3730 | Device, Voice Amplification | MCK |
876.1500 | Endoscopic Magnetic Retriever | FCC |
876.1500 | Light Source, Incandescent, Diagnostic. | FCQ |
876.1500 | Light Source, Photographic, Fiberoptic | FCR |
876.1500 | Light Source, Fiberoptic, Routine | FCW |
876.1500 | Carrier, Sponge, Endoscopic | FGS |
876.1500 | Light Source, Endoscope, Xenon Arc | GCT |
876.1500 | Transformer, Endoscope | GCW |
876.1500 | Scissors For Cystoscope | KGD |
876.1500 | LED Light Source | NTN |
876.1500 | Endoscopic Guide Wire, Gastroenterology-Urology. | OCY |
876.1500 | Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ |
876.4020 | Light, Catheter, Fiberoptic, Glass, Ureteral. | FCS |
876.4270 | Rod, Colostomy | EZP |
876.4400 | Ligator, Hemorrhoidal | FHN |
876.4400 | Ligator, Esophageal | MND |
876.4500 | Lithotriptor, Biliary Mechanical | LQC |
876.4770 | Urethrotome | EZO |
876.5010 | Bag, Bile Collecting | EXF |
876.5010 | Catheter, Biliary, Surgical | GCA |
876.5025 | Vibrator for Climax Control of Premature Ejaculation | PIA |
876.5365 | Dilator, Esophageal (Metal Olive) Gastro-Urology | EZM |
876.5365 | Bougie, Esophageal, and Gastrointestinal, Gastro-Urology. | FAT |
876.5365 | Dilator, Esophageal | KNQ |
876.5520 | Dilator, Urethral | KOE |
876.5630 | Catheter, Peritoneal, Long-Term Indwelling | FJS |
876.5630 | Catheter, Peritoneal Dialysis, Single Use. | FKO |
876.5630 | System, Peritoneal, Automatic Delivery. | FKX |
876.5665 | Disinfectant, Subsystem, Water Purification. | NIH |
876.5820 | Set, Dialyzer Holder | FKI |
876.5895 | Irrigator, Ostomy | EXD |
876.5980 | Catheter, Retention, Barium Enema With Bag. | FGD |
876.5980 | Gastrostomy Tube Holder | PLI |
878.4370 | Drape, Surgical, ENT | ERY |
878.4370 | Drape, Pure Latex Sheet, With Self-Retaining Finger Cot | EYX |
878.4370 | Drape, Urological, Disposable | EYY |
878.4370 | Pad, Kelly | FNW |
878.4370 | Drape, Patient, Ophthalmic | HMT |
878.4370 | Drape, Microscope, Ophthalmic | HMW |
878.4370 | Ring (Wound Protector), Drape Retention, Internal. | KGW |
878.4370 | Drape, Surgical | KKX |
878.4495 | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile. | GAQ |
878.4580 | Lamp, Operating-Room | FQP |
878.4580 | Light, Surgical, Instrument | FSQ |
878.4580 | Light, Surgical, Floor Standing | FSS |
878.4580 | Light, Surgical, Endoscopic | FSW |
878.4580 | Light, Surgical, Connector | FSX |
878.4580 | Light, Surgical, Ceiling Mounted | FSY |
878.4580 | Light, Surgical, Carrier | FSZ |
878.4580 | Light, Surgical, Accessories | FTA |
878.4580 | Lamp, Surgical | FTD |
878.4580 | Illuminator, Remote | FTG |
878.4580 | Lamp, Surgical, Incandescent | GBC |
878.5070 | Apparatus, Air Handling, Bench | FZG |
878.5070 | Apparatus, Air Handling, Room | FZH |
878.5070 | Apparatus, Air Handling, Enclosure | FZI |
880.5580 | Locator, Acupuncture Point | BWJ |
880.5580 | Needle, Acupuncture, Single Use | MQX |
880.5780 | Stocking, Medical Support (to Prevent Pooling of Blood in Legs). | DWL |
882.1020 | Analyzer, Rigidity | GZM |
882.1470 | Computerized Cognitive Assessment Aid. | PKQ |
882.1540 | Device, Galvanic Skin Response Measurement | GZO |
882.1560 | Device, Skin Potential Measurement | HCJ |
882.1855 | Encephalogram Telemetry System | GYE |
882.5895 | Vibratory Counter-Stimulation | OVP |
884.1630 | Colposcope (and Colpomicroscope) | HEX |
884.2990 | Sheet, Recording, Breast Examination. | NHM |
884.3200 | Drain, Cervical | HFL |
884.4400 | Forceps, Obstetrical | HDA |
884.4530 | Tenaculum, Uterine | HDC |
884.4530 | Clamp, Umbilical | HFW |
884.4530 | Speculum, Vaginal, Nonmetal | HIB |
884.4530 | Speculum, Vaginal, Nonmetal, Fiberoptic | HIC |
884.4530 | Clamp and Cutter, Umbilical | NBZ |
884.4900 | Table, Obstetrical, AC-Powered (and Accessories). | HDD |
884.4900 | Table, Obstetrical, Manual (and Accessories). | HHP |
884.4900 | Table, Obstetric (and Accessories) | KNC |
884.5200 | Hemorrhoid Prevention Pressure Wedge. | OOA |
884.5390 | Heater, Perineal, Direct Contact | HGZ |
884.5390 | Heater, Perineal, Radiant, Non-Contact. | HHA |
884.5390 | Heater, Perineal | KND |
884.5400 | Cup, Menstrual | HHE |
884.5425 | Pad, Menstrual, Scented | HHL |
884.6120 | Accessory, Assisted Reproduction | MQG |
884.6130 | Microtools, Assisted Reproduction (Pipettes). | MQH |
884.6150 | Micromanipulators and Microinjectors, Assisted Reproduction. | MQJ |
884.6160 | Labware, Assisted Reproduction | MQK |
886.1120 | Photorefractor | MMF |
886.1120 | Camera, Ophthalmic, General-Use | PJZ |
886.1250 | Euthyscope, AC-Powered | HMK |
886.1570 | Ophthalmoscope, AC-Powered | HLI |
886.1570 | Ophthalmoscope, Battery-Powered | HLJ |
886.1570 | Ophthalmoscopes, Replacement Batteries, Hand-Held. | MSG |
886.1780 | Retinoscope, AC-Powered | HKL |
886.1850 | Biomicroscope, Slit-Lamp, AC-Powered | HJO |
886.1945 | Transilluminator, AC-Powered | HJM |
886.3320 | Ocular Peg | MQU |
886.4150 | Tubing, Replacement, Phacofragmentation Unit | MSR |
886.4250 | Unit, Electrolysis, AC-Powered, Ophthalmic | HRO |
886.4335 | Headlight, Fiberoptic Focusing | FCT |
886.4335 | Light, Headband, Surgical | FSR |
886.4335 | Headlamp, Operating, AC-Powered | HPQ |
886.4400 | Locator, Metal, Electronic | HPM |
886.4440 | Magnet, AC-Powered | HPO |
886.4790 | Sponge, Ophthalmic | HOZ |
886.4790 | Eye Tray | OJK |
888.1240 | Dynamometer, AC-Powered | LBB |
888.4580 | Instrument, Surgical, Sonic and Accessory/Attachment | JDX |
888.4580 | System, Cement Removal Extraction | LZV |
890.1450 | Hammer, Reflex, Powered | IKO |
890.5100 | Bath, Hydro-Massage | ILJ |
890.5100 | Bath, Sitz, Powered | ILM |
890.5110 | Bath, Paraffin | IMC |
890.5250 | Cabinet, Moist Steam | IMB |
890.5360 | Exerciser, Measuring | ISD |
890.5500 | Lamp, Infrared, Therapeutic Heating | ILY |
890.5575 | Device, Warning, Overload, External Limb, Powered. | IRN |
892.1000 | MRI Disposable Kit | OIM |
892.1560 | Biopsy Needle Guide Kit | OIJ |
892.1610 | Aperature, Radiographic | IZS |
892.1610 | Cone, Radiographic | IZT |
892.1610 | Collimator, Automatic, Radiographic | IZW |
892.1610 | Collimator, Manual, Radiographic | IZX |
892.1610 | Device, Beam Limiting, X-Ray, Diagnostic. | KPW |
892.1650 | Arthrogram Tray | OII |
892.1650 | Radiology Dental Tray | OIK |
892.1670 | Device, Spot-Film | IXL |
892.1680 | Radiographic Contrast Tray | OIO |
892.1680 | Radiology Diagnostic Kit | OIP |
892.1730 | Discography Kit | OIL |
892.1820 | Chair, Pneumocephalographic | HBK |
892.1850 | Cassette, Radiographic Film | IXA |
892.1860 | Changer, Radiographic Film/Cassette | KPX |
892.1870 | Programmer, Changer, Film/Cassette, Radiographic | IZP |
892.1900 | Controller, Temperature, Radiographic. | EGT |
892.1900 | Dryer, Film, Radiographic | EGW |
892.1900 | Processor, Radiographic-Film, Automatic, Dental. | EGY |
892.1900 | Processor, Radiographic-Film, Automatic. | IXW |
892.1900 | Processor, Cine Film | IXX |
892.2030 | Digitizer, Image, Radiological | LMA |
892.2030 | Digitizer, Images, Ophthalmic | NFH |
892.2040 | Camera, Multi Format, Radiological | LMC |
892.2040 | Device, Hardcopy, Images, Ophthalmic. | NFI |
892.5730 | Prostate Seeding Kit | OIN |
奥咨达翻译团队根植于中国，面向全球，专注为医疗器械领域的企业提供专业、高效的翻译解决方案。翻译领域包括医疗器械的研发、注册、临床、上市后监督、营销、管理、培训等，译稿已涵盖医疗器械领域的所有类型。
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