Rfx+care Manufacturing Co., Ltd.
Manufacturer and brand owner in Shaoxing, Zhejiang, China. 21 device types, 3 products catalogued.
Rfx+care Manufacturing Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Condom, Retractor and 19 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | RFX+CARE MANUFACTURING CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007307589 |
| FEI number | 3007307589 |
| DUNS | 421146863 |
| Establishment type | Repacker / relabeller, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 绍兴瑞凯防护用品有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Shaoxing |
|---|---|
| Province | Zhejiang |
| Address | No.599-1F Wuxie Road |
| Postal code | 312000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bandage, Elastic | Class 1 | Rfx+care, Elastic bandage | 2015 | 280 |
| Bedding, Disposable, Medical | Class 1 | Emergency blanket | 2016 | 308 |
| Burn Kit With Drug | Class N | Burn kit | 2025 | 1 |
| Condom | Class 2 | m. Dior | 2022 | 9 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Rfx+care, Burn gel, Burn gel dressing | 2015 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Rfx+care, Dry swab, Sterile wound compress | 2015 | 195 |
| Dressing, Wound, Occlusive | Class 1 | After Bites, Spot Patch, Blister Plaster, Hydrocolloid Dressing, Acne Patch, Insect Bites Patch and 2 more | 2016 | 183 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face mask | 2020 | 182 |
| First Aid Kit With Drug | Class N | Rfx+care | 2016 | 57 |
| First Aid Kit Without Drug | Class 1 | Boss, Vitronic, First Aid Kit, Rfx+care | 2008 | 132 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Rfx+care, Sterile Wound bandage, Wound dressing | 2015 | 266 |
| Mask, Surgical | Class 2 | surgical face mask | 2021 | 125 |
| Pack, Hot Or Cold, Disposable | Class 1 | Body warmer, Rfx+care, Ice pack | 2015 | 176 |
| Pack, Hot Or Cold, Reusable | Class 1 | Cold /Hot pack, Hot/cold compress | 2025 | 178 |
| Retractor | Class 1 | Tick remover | 2025 | 34 |
| Sling, Arm | Class 1 | Triangular bandage | 2016 | 126 |
| Strip, Adhesive, Closure, Skin | Class 1 | Skin closure strip | 2016 | 14 |
| Strip, Temperature, Forehead, Liquid Crystal | Class 2 | Rfx+care, Forehead thermometer | 2015 | 17 |
| Tape And Bandage, Adhesive | Class 1 | Rfx+care, Plaster, adhesive tape, Bee plaster, Barbie Collection Water-Proof Adhesive Bandages Set | 2013 | 353 |
| Toothbrush, Manual | Class 1 | Rfx+care, Toothbrush | 2013 | 244 |
| Vinyl Patient Examination Glove | Class 1 | Disposable Gloves, Vinyl Patient Examination Glove-Disposable Gloves, Vinyl Patient Examination Gloves, Examination Gloves | 2020 | 72 |
Own-Brand Listings
Clearances
No clearance names Rfx+care Manufacturing Co., Ltd. as applicant. 4 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K203190 | 2021-06-02 | FXX | Traditional | Rfx+Care Manufactoring Co., Ltd. |
| K131832 | 2014-01-07 | LYZ | Traditional | Shandong Binxiang Medical Products Co., Ltd. |
| K083817 | 2009-09-16 | HIS | Abbreviated | Suzhou Colour-Way Enterprise Development Co., Ltd. |
| K931005 | 1993-07-14 | FPX | Traditional | Dukal LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1979 |
|---|---|
| Factory area | 39,000 sq m |
| Main products | First aid supplies, Wound care products, Sports care solutions, PPE, Pharmaceuticals |
| Certifications | ISO 14001:2015, ISO 9001:2015, FDA, Amfori BSCI, SEDEX, BRC Global Standards, MDR |
| Export markets | 12 countries |
| OEM and ODM | Offered |
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.
The manufacturer named here can complete this record.