FDA Registration
Active
🇨🇳 China
CAREMAX CO., LTD.
Reg #: 3004704697
·
FEI: 3004704697
·
Expires 2026
Products
20
Proprietary Names
20
Establishment Types
4
Classifications
20
Registration Details
- Registration Name
- CAREMAX CO., LTD.
- Registration Number
- 3004704697
- FEI Number
- 3004704697
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 43 SHUANGJING STREET, FENG TING ROAD
- City
- SUZHOU, JIANGSU PROVINCE
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213040
Owner / Operator
- Firm Name
- CAREMAX CO., LTD.
- Operator Number
- 9065435
- Address
- NO. 43 SHUANGJING STREET, FENG TING ROAD
- City
- SUZHOU, JIANGSU PROVINCE
- State
- CN-NOTA
- Postal Code
- 215121
- Country
- CN
US Agent
- Business Name
- AJW Technology Consultants, Inc.
- Contact Name
- Jon Ward
- Address
- 11705 Boyette Road, #503
- City
- Riverview
- State
- FL
- ZIP
- 33569
- Country
- US
- [email protected]
- Phone
- 813 6452855 ext. 104
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pad, Alcohol, Device Disinfectant | LKB | Class U | Unknown | No | 2020-05-29 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2015-04-22 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2012-07-11 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2017-03-29 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-12-08 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-12-08 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-12-08 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-12-08 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2007-11-07 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2008-03-28 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2020-12-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2007-11-07 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2007-11-07 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2022-11-29 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2007-11-07 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2007-11-07 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2004-07-30 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2017-05-01 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2016-06-28 |
| Tourniquet Kit | OJS | Class 1 | General, Plastic Surgery | No | 2021-01-20 |
Proprietary Names
Alcohol Prep Pads
Compression Dressing
Tweezers, plastic
Medical Scissors, Disposable
NITRILE PATIENT EXAMINATION GLOVES
ARM SLING, TRIANGULAR BANDAGE, MULT
Gauze Sponge
Vinyl Examination Gloves
Adhesive Bandages
Adhesive Strips
KIT, FIRST AID (MULTIPLE BRANDS)
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES
Mask, surgical
DISPOSABLE BEDDING
FIBER, MEDICAL, ABSORBENT
TRAUMA DRESSING, ROLLED GAUZE BANDA
CAREMAX COHESIVE BAND
CPR Face Shield
Tourniquet Kit
Mask, Cone Shaped, White
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device