FDA Registration
Active
🇰🇷 South Korea
Electrosurgical, cutting & coagulation & accessories
Reg #: 3029916132
·
FEI: 3029916132
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BRITZMEDI CO.,LTD
- Registration Number
- 3029916132
- FEI Number
- 3029916132
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1F, 2 Gisan-ro 87 beon-gil
- City
- Hwaseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K212561
Owner / Operator
- Firm Name
- Britzmedi Co.,Ltd
- Operator Number
- 10088936
- Address
- 1F, 2 Gisan-ro 87 beon-gil
- City
- Hwaseong-si
- State
- Gyeonggi
- Postal Code
- 18387
- Country
- KR
- Correspondent
- DONG HOO KIM
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-10-23 |
Proprietary Names
Electrosurgical, cutting & coagulation & accessories
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)