Xiamen Zhiyuan Medical Technology Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 22 device types.
Xiamen Zhiyuan Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Dilator, Nasal and 20 other device types. Its earliest product listing with the FDA dates from 2023.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3027605742 |
| FEI number | 3027605742 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | 3RD Floor, No.208, SIMING PARK, XINMIN TOWN, TONG’AN DISTRICT |
| Postal code | 361100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Disposable medical face mask (non-sterile):BLYY001 | 2023 | 439 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Oropharyngeal airway | 2023 | 84 |
| Cassettes, Tissue | Class 1 | Embedding Cassette | 2024 | 16 |
| Container, Specimen Mailer And Storage, Sterile | Class 1 | centrifuge tube, Sample Collector | 2023 | 33 |
| Container, Specimen, Non-Sterile | Class 1 | Container, Specimen, NON-Sterile | 2023 | 115 |
| Container, Specimen, Sterile | Class 1 | Cryovial Tube | 2024 | 79 |
| Dilator, Nasal | Class 1 | mouth tape, nasal dilator, nasal strips | 2025 | 55 |
| Dish, Tissue Culture | Class 1 | Cell culture Plate, deep well plate, ELISA plate, Cell culture Dish, Cell culture Flask | 2023 | 30 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | pcr plate PCR, buffer tube | 2023 | 72 |
| Irrigator, Sinus | Class 1 | nasal rinse, nasal aspirator, nasal irrigation | 2025 | 27 |
| Mask, Gas, Anesthetic | Class 1 | anesthesia face mask | 2023 | 71 |
| Mask, Oxygen | Class 1 | Oxygen Mask | 2023 | 126 |
| Material, Impression Tray, Resin | Class 1 | Impression Tray | 2023 | 41 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Nebulizer Mask | 2023 | 57 |
| Pump, Nebulizer, Electrically Powered | Class 1 | Disposable Medical Aerosol Mask | 2023 | 15 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | protection glasses: BLYY001 | 2023 | 384 |
| Speculum, Vaginal, Metal | Class 1 | Vaginal Speculum | 2023 | 8 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | Class 2 | Oxygen Cannula | 2023 | 6 |
| Syringe, Periodontic, Endodontic, Irrigating | Class 1 | Surgical Aspirator Tips, AirWater Syringe Tip | 2023 | 32 |
| Trap, Sterile Specimen | Class 2 | Bone Dust Trap | 2025 | 19 |
| Tray, Impression, Preformed | Class 1 | RESIN, MATERIAL, Impression Tray | 2023 | 73 |
| Tube, Collection, Capillary Blood | Class 1 | Quantitative Blood Sample Collector, Blood tube | 2023 | 16 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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