FDA Registration
Active
🇰🇷 South Korea
PURGO BIOLOGICS INC.
Reg #: 3014448321
·
FEI: 3014448321
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- PURGO BIOLOGICS INC.
- Registration Number
- 3014448321
- FEI Number
- 3014448321
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #812, 27, Dunchon-daero 457 beon-gil,Jungwon-gu
- City
- Seongnam-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K230091
Owner / Operator
- Firm Name
- PURGO BIOLOGICS Inc.
- Operator Number
- 10053793
- Address
- #812, 27 Duncheon-daero, 457 beon-gil, Jungwon-gu
- City
- Seongnam-si
- State
- Gyeonggi
- Postal Code
- 13219
- Country
- KR
- Correspondent
- Byungsun Kim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2023-10-10 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2024-07-25 |
| Barrier, Synthetic, Intraoral | NPK | Class 2 | Dental | No | 2023-05-14 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | Class 2 | General, Plastic Surgery | No | 2019-07-19 |
Proprietary Names
THE Cover
THE Graft Collagen
CYTOSHIELD
OpenTex
TBS PTFE Membrane
Biotex
TBS PTFE Suture
THE Graft
Establishment Types
Manufacture Medical Device