FDA Registration
Active
🇻🇳 Vietnam
INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED
Reg #: 3016096058
·
FEI: 3016096058
·
Expires 2026
Products
10
Proprietary Names
10
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED
- Registration Number
- 3016096058
- FEI Number
- 3016096058
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LOT CN-03, Dong Mai Industrial Park,
- City
- Dong Mai Ward Quang Ninh
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K053254
Owner / Operator
- Firm Name
- INTCO MEDICAL TECHNOLOGY VIET NAM COMPANY LIMITED
- Operator Number
- 10061749
- Address
- LOT CN-03, Dong Mai Industrial Park,
- City
- Dong Mai Ward
- State
- Quang Ninh
- Postal Code
- 01000
- Country
- VN
- Correspondent
- Max Li
US Agent
- Business Name
- Primemax
- Contact Name
- Max Lee
- Address
- 805 Barrington Ave
- City
- Ontario
- State
- CA
- ZIP
- 91764
- Country
- US
- [email protected]
- Phone
- 909 9801678
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2025-06-04 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2025-03-17 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2025-08-11 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2023-05-30 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2019-11-15 |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | Class 1 | Physical Medicine | No | 2019-11-15 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2019-11-15 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2024-06-11 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2021-12-30 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2025-03-17 |
Proprietary Names
Overbed Table
Polyethylene Gowns,Non-surgical
heat patch
Electrode
TENS Electrode
PACK, HOT OR COLD, DISPOSABLE
Infant heel warmer (chemical heat pack)
Pack, hot or cold, reusable
Surgical face mask
Polyethylene Gowns, Examination
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)