Data / Medical devices / China / Caremax Co., Ltd.
Caremax Co., Ltd.: FDA-registered device maker in Suzhou, Jiangsu Province, China, 4 510(k) clearances
Caremax Co., Ltd. is registered with the FDA (registration 3004704697) in Suzhou, Jiangsu Province, China. It lists 17 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004704697
- Address
- No. 43 Shuangjing Street Feng Ting Road, Suzhou, Jiangsu Province, China, 215121
- Owner or operator
- CAREMAX CO., LTD. (9065435)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- July 30, 2004
- Registered through
- 2026
- Brand names listed
- ARM SLING, TRIANGULAR BANDAGE, MULT, Adhesive Bandages, Adhesive Strips, Alcohol Prep Pads, CAREMAX COHESIVE BAND, CPR Face Shield, Compression Dressing, DISPOSABLE BEDDING 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 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dressing, Compression | MHW | 1 | Contract manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| First Aid Kit With Drug | LRR | N | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| First Aid Kit Without Drug | OHO | 1 | Contract manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Exporter to the US | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Oxygen, Non-Rebreathing | KGB | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Exporter to the US | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Medical, Disposable | JOK | 1 | Exporter to the US | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tourniquet Kit | OJS | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Foreign private label distributor, 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 |
|---|---|---|---|---|---|---|
| March 29, 2021 | K202191 | Surgical Mask | FXX | Substantially Equivalent | Wuhan Zonsen Medical Products Co., Ltd. | accessdata.fda.gov |
| March 25, 2015 | K142892 | Powder-free Clear Vinyl Patient Examination Gloves | LYZ | Substantially Equivalent | Shenyi (Shandong) Plastic Products Co., Ltd. | accessdata.fda.gov |
| October 16, 2012 | K121992 | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR | LZA | Substantially Equivalent | Xinwei (Shandong) Plastic and Rubber Products Co., | accessdata.fda.gov |
| September 15, 2006 | K061864 | DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560 | FXX | Substantially Equivalent | Dukal Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Sling, Arm
- All makers of Scissors, Medical, Disposable
- All makers of Fiber, Medical, Absorbent
- All makers of Bandage, Elastic
- All makers of First Aid Kit Without Drug
Updated March 29, 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.