Caremax Co., Ltd.
Registered establishment in Suzhou, Jiangsu Province, China. 17 device types.
Caremax Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Forceps, Sling, Arm and 15 other device types. Its earliest product listing with the FDA dates from 2004.
Registration
| Registered name | CAREMAX CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004704697 |
| FEI number | 3004704697 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
Location
| City | Suzhou, Jiangsu Province |
|---|---|
| Address | NO. 43 SHUANGJING STREET |
| Postal code | 215121 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bandage, Elastic | Class 1 | Caremax Cohesive Band | 2004 | 280 |
| Bedding, Disposable, Medical | Class 1 | Disposable Bedding | 2007 | 308 |
| Dressing, Compression | Class 1 | Compression Dressing | 2015 | 87 |
| Fiber, Medical, Absorbent | Class 1 | Fiber, Medical, Absorbent, Trauma Dressing, Rolled Gauze Banda | 2007 | 172 |
| First Aid Kit With Drug | Class N | KIT, First AID (Multiple Brands) | 2007 | 57 |
| First Aid Kit Without Drug | Class 1 | 2016 | 132 | |
| Forceps | Class 1 | Tweezers, plastic | 2012 | 99 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze Sponge | 2008 | 266 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | CPR Face Shield | 2017 | 72 |
| Mask, Surgical | Class 2 | Mask, Cone Shaped, White, Mask, surgical | 2008 | 125 |
| Pad, Alcohol, Device Disinfectant | Class U | Alcohol Prep Pads | 2020 | 49 |
| Polymer Patient Examination Glove | Class 1 | Polymer patient examination glove | 2026 | 83 |
| Scissors, Medical, Disposable | Class 1 | Medical Scissors, Disposable | 2017 | 36 |
| Sling, Arm | Class 1 | ARM Sling, Triangular Bandage, Mult | 2007 | 126 |
| Tape And Bandage, Adhesive | Class 1 | Adhesive Bandages, Adhesive Strips | 2007 | 353 |
| Tourniquet Kit | Class 1 | Tourniquet Kit | 2021 | 2 |
| Vinyl Patient Examination Glove | Class 1 | Vinyl patient examination glove | 2026 | 72 |
Clearances
No clearance names Caremax 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 |
|---|---|---|---|---|
| K202191 | 2021-03-29 | FXX | Traditional | Wuhan Zonsen Medical Products Co., Ltd. |
| K142892 | 2015-03-25 | LYZ | Traditional | Shenyi Shandong Plastic Products Co Ltd |
| K121992 | 2012-10-16 | LZA | Traditional | Xinwei (Shandong) Plastic AND Rubber Products Co Ltd. |
| K061864 | 2006-09-15 | FXX | Traditional | Dukal LLC |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Factory area | 40000 m² |
| Main products | Adhesive bandages, Cohesive bandages, First aid kits, Triangular bandages, Survival blankets |
| Certifications | FDA, ISO13485, CE |
| Export markets | 60+ countries and regions |
| OEM and ODM | Offered |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Suzhou Suning Underpad Co., Ltd. | 11 |
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.