FDA Registration
Active
🇧🇲 Bermuda
Isolation Gown
Reg #: 3017171460
·
FEI: 3017171460
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEDTECS INTERNATIONAL CORPORATION LIMITED
- Registration Number
- 3017171460
- FEI Number
- 3017171460
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Clarendon House, 2 Church Street
- City
- City of Hamilton
- Country
- BM
Regulatory Submissions
- 510(k) Number
- K190306
Owner / Operator
- Firm Name
- Medtecs (Taiwan) Corp.
- Operator Number
- 10074525
- Address
- 11F., No. 9, Songgao Road, Xinyi Dist.
- City
- Taipei City
- State
- TW-TPE
- Postal Code
- 11073
- Country
- TW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2023-08-16 |
Proprietary Names
Isolation Gown
Establishment Types
Export Device to the United States But Perform No Other Operation on Device