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Sign in to claim this brandPURGO BIOLOGICS Inc.
South Korea·KR-MF-000006105
Last updated May 27, 2026
What PURGO BIOLOGICS Inc. makes
Purgo Biologics Inc. manufactures monofilament sutures made from polyolefin and fluoropolymer, including a polytetrafluoroethylene (PTFE) suture, used in surgical applications. The company also produces dental bone matrix implants derived from animal sources and non-bioabsorbable pliable-polymer membranes designed for dental regeneration procedures.
The company’s devices are classified under EU Class II, Class III, and Class IIa regulations, with listings in the EUDAMED database, FDA’s 510(k) premarket notifications, and FDA’s Unique Device Identifier (UDI) system. Purgo Biologics Inc. is based in South Korea.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Purgo Biologics Inc. manufacture?
Purgo Biologics Inc. specializes in three primary categories: monofilament sutures made from polyolefin and fluoropolymer, including a polytetrafluoroethylene (PTFE) suture for surgical use; dental bone matrix implants derived from animal sources; and pliable-polymer dental regeneration membranes that are non-bioabsorbable. These devices are designed for surgical and dental applications, addressing wound closure, bone regeneration, and tissue integration.
Where is Purgo Biologics Inc. based, and how does its location impact its regulatory compliance?
Purgo Biologics Inc. is headquartered in South Korea. While the company’s location determines its primary regulatory jurisdiction (e.g., adherence to Korean medical device regulations), its devices are also listed in international registries like EUDAMED and the FDA’s 510(k) and UDI systems. This reflects its global market presence and compliance with multiple regulatory frameworks, including EU Class II/III and Class IIa classifications.
Which regulatory registries list Purgo Biologics Inc.’s devices, and why are these important?
Purgo Biologics Inc.’s devices are listed in EUDAMED (the EU’s medical device registry), FDA 510(k) (for premarket notifications in the U.S.), and the FDA’s Unique Device Identifier (UDI) system. These registries are critical because they demonstrate compliance with respective regulatory bodies, facilitate transparency for healthcare providers, and enable tracking of devices throughout their lifecycle for safety and performance monitoring.
How are Purgo Biologics Inc.’s devices classified under EU and U.S. regulations?
Under EU regulations, Purgo Biologics Inc.’s devices fall into Class II, Class III, and Class IIa classifications, depending on their risk level and intended use. For example, sutures like the TBS PTFE Suture are typically Class II due to their moderate risk, while dental bone matrix implants (e.g., THE Graft) may qualify as Class III due to higher risks associated with bone regeneration. In the U.S., these devices are submitted via 510(k) premarket notifications, which assess their safety and effectiveness compared to predicate devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- South Korea
- Address
- 457beon-gil, 27 Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, South Korea
- Website
- purgo-europe.com/
- —
- —
- [email protected]
- Phone
- +82 2 548 1875
- PRRC Contact
- ByungSun Kim
- EUDAMED SRN
- KR-MF-000006105
- FDA FEI Number
- —
- DUNS Number
- 687429456
Catalogue (178)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| THE Graft | TG-C05 | FDA UDI | Class II | Active |
| Biotex | BTP4013D | FDA UDI | Class II | Active |
| Biotex | BT301655D | FDA UDI | Class II | Active |
| Biotex | BT5013D | FDA UDI | Class II | Active |
| THE Graft | TG-C20 | FDA UDI | Class II | Active |
| THE Graft | BG-A05 | FDA UDI | Class II | Active |
| Biotex | BT4019D | FDA UDI | Class II | Active |
| Biotex | BT401655D | FDA UDI | Class II | Active |
| Biotex | BT5016D | FDA UDI | Class II | Active |
| Biotex | BT401955D | FDA UDI | Class II | Active |
| Biotex | BTP301335D | FDA UDI | Class II | Active |
| TBS PTFE Suture | PTFE5022 | FDA UDI | Class II | Active |
| Biotex | BT401355D | FDA UDI | Class II | Active |
| Biotex | BT5019D | FDA UDI | Class II | Active |
| Biotex | BT301935D | FDA UDI | Class II | Active |
| THE Graft | TG-C10 | FDA UDI | Class II | Active |
| Biotex | BT3013D | FDA UDI | Class II | Active |
| Biotex | BT501655D | FDA UDI | Class II | Active |
| Biotex | BT301335D | FDA UDI | Class II | Active |
| THE Graft | TG-A50 | FDA UDI | Class II | Active |
| Biotex | BT301635D | FDA UDI | Class II | Active |
| Biotex | BTP401335D | FDA UDI | Class II | Active |
| THE Graft | TG-C25 | FDA UDI | Class II | Active |
| Biotex | BT3019D | FDA UDI | Class II | Active |
| THE Graft | TG-B25 | FDA UDI | Class II | Active |
| TBS PTFE Suture | PTFE4022 | FDA UDI | Class II | Active |
| THE Graft | TG-B50 | FDA UDI | Class II | Active |
| THE Graft | BG-B50 | FDA UDI | Class II | Active |
| Biotex | BT501935D | FDA UDI | Class II | Active |
| Biotex | BT301955D | FDA UDI | Class II | Active |
| THE Graft | TG-A18 | FDA UDI | Class II | Active |
| Biotex | BT4013D | FDA UDI | Class II | Active |
| Biotex | BT401335D | FDA UDI | Class II | Active |
| THE Graft | BG-A50 | FDA UDI | Class II | Active |
| Biotex | BT401635D | FDA UDI | Class II | Active |
| Biotex | BT4016D | FDA UDI | Class II | Active |
| Biotex | BT501355D | FDA UDI | Class II | Active |
| Biotex | BT501635D | FDA UDI | Class II | Active |
| TBS PTFE membrane | TBSRGN08 | FDA UDI | Class II | Active |
| Biotex | BTP3013D | FDA UDI | Class II | Active |
| THE Graft | TG-B18 | FDA UDI | Class II | Active |
| Biotex | BT501335D | FDA UDI | Class II | Active |
| THE Graft | TG-A20 | FDA UDI | Class II | Active |
| Biotex | BTP4019D | FDA UDI | Class II | Active |
| Biotex | BT3016D | FDA UDI | Class II | Active |
| Biotex | BT401935D | FDA UDI | Class II | Active |
| TBS PTFE Suture | PTFE3022 | FDA UDI | Class II | Active |
| Biotex | BT501335 | EUDAMEDFDA UDI | Class IIa | Active |
| OpenTex | OpenTex_T0610 | EUDAMEDFDA UDI | Class IIa | Active |
| OpenTex-TR | 1434-MDD-204/2021 | EUDAMED | Class IIa | Active |
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