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THE Cover

by Purgo Biologics Inc. 8 variants

Ref BP5-1530

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 Number08800039003797 UDI-DI Date31 Oct 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-08800039003797 Basic UDI-DI 08800039003797UDI-DIDate28 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  • Withdrawn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
Collagen dental regeneration membrane
Model / Reference
BP5-1530
Primary DI / UDI-DI
08800039003797
Basic UDI-DI
B-08800039003797
510(k) Number
FDA Product Code
NPL
EMDN Code
Q010301 Periodontal membranes
GMDN Term
Collagen dental regeneration membrane
Device Class
Class III 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 III
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
  • Implantable
  • Animal Tissues
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human 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