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OpenTex-TR

by Purgo Biologics Inc. South Korea EUDAMED

Ref OpenTex-TR_P0205 EMDN Q010301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800039001489 Basic UDI-DIDate2 Mar 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
OpenTex-TR_P0205
Primary DI / UDI-DI
08800039001489
Basic UDI-DI
B-08800039001489
EMDN Code
Q010301 Periodontal membranes
Device Class
Class IIa
Market of Registration
Italy

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 & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • 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

Sources (1)

  • EUDAMED 02624110-6def-426d-aae7-40cbf2c65c69 61 fields · synced 24 Oct 2026