Data / Medical devices / China / Zhejiang Hongyu Medical Commodity Co., Ltd.
Zhejiang Hongyu Medical Commodity Co., Ltd.: FDA-registered device maker in YIWU Zhejiang, China, 1 510(k) clearance
Zhejiang Hongyu Medical Commodity Co., Ltd. is registered with the FDA (registration 3005083505) in YIWU Zhejiang, China. It lists 36 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005083505
- Address
- No.668,ChanHua Road,Industrial Functional Area,Fotang Town, YIWU Zhejiang, China, 322002
- Owner or operator
- ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD. (9071821)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- March 29, 2005
- Registered through
- 2026
- Brand names listed
- 10788 baby healthcare kit, 30 pcs, 40 pcs, 50 pcs, ABD Combine Pad, 5 x 9, Alcohol Prep Pad/Cleansing Pads,BZK Antiseptic Swab, Alginate Dressings; foam dressing, hydrogel dressing,I.V. dressing;Wound Dressing,Hydrocollid dressing, BANDAGE, ELASTIC, CMC Gelling Fiber Dressing, Cotton Ball and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Adaptor, Dressing | ILD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Adhesive Backed Thermal Skin Patches | OMW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bandage, Liquid, Skin Protectant | NEC | 1 | Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Contract manufacturer | accessdata.fda.gov |
| Crutch | IPR | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Depressor, Tongue, Non-Surgical | FMA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Device, Fixation, Tracheal Tube | CBH | 1 | Manufacturer | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Eye | HMP | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | PYO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Tourniquet, Nonpneumatic | GAX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2021 | K211897 | Surgical Face Mask | FXX | Substantially Equivalent | Zhejiang Hongyu Medicali Commodity Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bandage, Liquid, Skin Protectant
- All makers of First Aid Kit Without Drug
- All makers of Tourniquet, Nonpneumatic
- All makers of First Aid Kit With Drug
- All makers of Dressing, Wound, Hydrophilic
- All makers of Mask, Surgical
Updated August 3, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.