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OpenTex-TR

by Purgo Biologics Inc. South Korea EUDAMED

Ref OpenTex-TR_0605

EMDN Q010301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800039001137 Basic UDI-DIDate2 Mar 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
OpenTex-TR_0605
Primary DI / UDI-DI
08800039001137
Basic UDI-DI
B-08800039001137
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 63aca5f5-2637-4662-9b7f-0d959fd1579d 61 fields · synced 22 Oct 2026