Data / Medical devices / China / Rfx+care Manufacturing Co., Ltd.
Rfx+care Manufacturing Co., Ltd.: FDA-registered device maker in Shaoxing Zhejiang, China, 4 510(k) clearances
Rfx+care Manufacturing Co., Ltd. is registered with the FDA (registration 3007307589) in Shaoxing Zhejiang, China. It lists 21 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007307589
- Address
- No.599-1F Wuxie Road Yuecheng District, Shaoxing Zhejiang, China, 312000
- Owner or operator
- RFX+CARE Manufacturing Co., Ltd. (10027255)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- October 17, 2008
- Registered through
- 2026
- Brand names listed
- Acne Patch, After Bites, BOSS, Barbie Collection Water-Proof Adhesive Bandages Set, Bee plaster, Blemish Patch, Blister Plaster, Body warmer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Burn Kit With Drug | OJI | N | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Condom | HIS | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Exporter to the US, Manufacturer | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Exporter to the US, Manufacturer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Disposable | IMD | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Strip, Adhesive, Closure, Skin | FPX | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Exporter to the US, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 2, 2021 | K203190 | Surgical Face Mask | FXX | Substantially Equivalent | Rfx+Care Manufactoring Co., Ltd. | accessdata.fda.gov |
| January 7, 2014 | K131832 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | Substantially Equivalent | Shandong Binxiang Medical Products Co., Ltd. | accessdata.fda.gov |
| September 16, 2009 | K083817 | M. DIOR BRAND | HIS | Substantially Equivalent | Suzhou Colour-Way Enterprise Development Co., Ltd. | accessdata.fda.gov |
| July 14, 1993 | K931005 | DUKAL SKIN CLOSURE STRIP | FPX | Substantially Equivalent | Dukal Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Strip, Temperature, Forehead, Liquid Crystal
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Pack, Hot Or Cold, Disposable
- All makers of Bedding, Disposable, Medical
- All makers of Mask, Surgical
- All makers of Strip, Adhesive, Closure, Skin
Updated June 2, 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.