FDA Registration
Active
🇭🇰 Hong Kong
U&U MEDICAL TECHNOLOGY CO., LTD
Reg #: 3014456066
·
FEI: 3014456066
·
Expires 2026
Products
13
Proprietary Names
14
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- U&U MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3014456066
- FEI Number
- 3014456066
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN ,
- City
- hongkong
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K132552
Owner / Operator
- Firm Name
- U&U Medical Technology Co., Ltd
- Operator Number
- 10057703
- Address
- RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN ,
- City
- hongkong
- State
- HK-NOTA
- Postal Code
- 11702
- Country
- HK
- Correspondent
- Nick wang
US Agent
- Business Name
- Carelife USA Inc.
- Contact Name
- LI QIAN
- Address
- 1120 Alpha Dr
- City
- Alpharetta
- State
- GA
- ZIP
- 30004
- Country
- US
- [email protected]
- Phone
- 770 9356499
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-09-06 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2019-07-24 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2020-11-09 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2018-05-15 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2018-05-15 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2018-06-21 |
| Enteral Syringes With Enteral Specific Connectors | PNR | Class 2 | Gastroenterology, Urology | No | 2020-12-14 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2020-11-02 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2019-09-06 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2019-09-06 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2018-06-13 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2022-09-21 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2020-11-09 |
Proprietary Names
NEEDLE
INFUSION SETS
Dental Syringe
PEN NEEDLE
Sterilization Pouch ETO and STEAM
U&U PISTON SYRINGE
SAFETY NEEDLE
ENTERAL SYRINGE
MERIT SYRINGE CAP
Insulin syringe
PLASTIC NEEDLE BLUNT NEEDLE
Blunt Needle Plastic
Tourniquet
Dental Needle
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device