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Biotex

by Purgo Biologics Inc. 29 variants

Ref BT501655

Biotex (BT501655) is a device classified as Class IIa in the EU and Class II in the US made by PURGO BIOLOGICS Inc., registered in EUDAMED on 23 Feb 2022 (Basic UDI-DI B-08800039003308), cleared under FDA 510(k) K180992 on 16 Jul 2019 and listed in FDA GUDID since 6 Apr 2020 (UDI-DI 08800039003308), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180992

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800039003308 Basic UDI-DI 08800039003308UDI-DIDate23 Feb 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number08800039003308 UDI-DI Date6 Apr 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK180992 Date16 Jul 2019IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800039003308 registered 23 Feb 2022 Active
  • FDA 510(k) K180992 decided 16 Jul 2019 Active
  • FDA GUDID UDI-DI 08800039003308 listed 6 Apr 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180992
  2. Listed FDA GUDID 08800039003308
  3. Registered EUDAMED B-08800039003308

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Polyolefin/fluoropolymer suture, monofilament
Model / reference
BT501655
Primary DI / UDI-DI
08800039003308
Basic UDI-DI
B-08800039003308
510(k) Number
FDA product code
NBY
EMDN code
H010201010501 Polytetrafluoroethylene (ptfe) monofilament with needle
GMDN term
Polyolefin/fluoropolymer suture, monofilament
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.5035
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
KR-MF-000006105
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Polyolefin/fluoropolymer suture, monofilament

Similar devices in this category

Other devices filed under POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE.

Other devices from PURGO BIOLOGICS Inc.

See all devices from PURGO BIOLOGICS Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)