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OpenTex

by Purgo Biologics Inc. 36 variants

Ref OpenTex_0305

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800039000697 UDI-DI Date17 May 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08800039000697 Basic UDI-DI 08800039000697UDI-DIDate24 Feb 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Pliable-polymer dental regeneration membrane, non-bioabsorbable
Model / Reference
OpenTex_0305
Primary DI / UDI-DI
08800039000697
Basic UDI-DI
B-08800039000697
510(k) Number
FDA Product Code
NPK
EMDN Code
Q010301 Periodontal membranes
GMDN Term
Pliable-polymer dental regeneration membrane, non-bioabsorbable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3930
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Other devices from PURGO BIOLOGICS Inc.

See all devices from PURGO BIOLOGICS Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No