Identity
- Trade Name
- Biotex EUDAMEDFDA UDI
- Generic Name
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
- Device Name
- Biotex EUDAMED
- Model / Reference
- BT5019 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800039000369 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800039000369 EUDAMED
- 510(k) Number
- K180992 FDA UDI
- FDA Product Code
- NBY FDA UDI
- EMDN Code
- H010201010501 POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE EUDAMED
- GMDN Term
- Polyolefin/fluoropolymer suture, monofilament FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5035 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polyolefin/fluoropolymer suture, monofilament
Biotex by PURGO BIOLOGICS Inc. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180992 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08800039000369 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Purgo Biologics Inc.
- EUDAMED SRN
- KR-MF-000006105
- FDA Applicant
- Purgo Biologics, Inc.
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED cdf76b0f-515d-4a1f-abef-555a3e067dde 85 fields · synced Jun 18, 2026
- FDA UDI b45c622a-afc0-4a63-a99a-1214453ef6f0 33 fields · synced May 30, 2026
- FDA 510(k) K180992 1 fields · synced May 18, 2026