FDA Registration
Active
🇻🇳 Vietnam
THANH HOA MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3038277359
·
FEI: 3038277359
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- THANH HOA MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3038277359
- FEI Number
- 3038277359
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT CN - 06 NORTHERN ZONE A, BIM SON PARK
- City
- QUANG TRUNG WARD Thanh Hoa
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K243441
Owner / Operator
- Firm Name
- Thanh Hoa Medical Technology Co., Ltd.
- Operator Number
- 10093306
- Address
- LOT CN - 06 NORTHERN ZONE A, BIM SON PARK
- City
- QUANG TRUNG WARD
- State
- Thanh Hoa
- Postal Code
- 440000
- Country
- VN
- Correspondent
- Tram MAI Thi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2025-11-21 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-11-21 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-11-21 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-11-21 |
Proprietary Names
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device