FDA Registration
Active
🇻🇳 Vietnam
SANMU (VIETNAM) PROTECTIVE PRODUCTS CO., LTD
Reg #: 3019848304
·
FEI: 3019848304
·
Expires 2026
Products
11
Proprietary Names
14
Establishment Types
3
Classifications
11
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Registration Details
- Registration Name
- SANMU (VIETNAM) PROTECTIVE PRODUCTS CO., LTD
- Registration Number
- 3019848304
- FEI Number
- 3019848304
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lot C1, Road No. 8, Hai Son Industrial Park (Phase 3&4), Binh Tien 2 Hamlet
- City
- Duc Hoa Commune Tay Ninh
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K202191
Owner / Operator
- Firm Name
- SANMU (VIETNAM) PROTECTIVE PRODUCTS CO., LTD
- Operator Number
- 10082398
- Address
- No. 11, Lot 2-4-6-8, An Ha Street, Tan Duc Industrial Park
- City
- Duc Hoa Commune
- State
- Tay Ninh
- Postal Code
- 82700
- Country
- VN
- Correspondent
- Lei Xia
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2023-11-08 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2024-11-07 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2021-07-22 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2021-07-22 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2021-07-22 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2026-05-05 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2023-11-08 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2021-07-22 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2023-11-08 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2021-07-22 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2024-06-12 |
Proprietary Names
Surgical Mask
CSR Wrap
Scrub suit
Shoe cover
Surgical masks
Gemini Sterilization Wrap
Doctor cap
Professional towels
Exam table paper
Disposable Medical Bedding
Patient examination gown
Surgical Drape
Isolation gown, Protective coverall
Coverall
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device