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Uni Cover

by Sion Biotext Medical Ltd. EUDAMED

Active European Union

Ref 53NS2223

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07290108302837 Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

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.

Specification

EUDAMED

Device Name
Uni Cover
Model / Reference
53NS2223
Primary DI / UDI-DI
07290108302837
Basic UDI-DI
B-07290108302837
EMDN Code
T030199 Covers, instruments and equipment - other
Device Class
Class I
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
IL-MF-000012169
Authorised representative
Theo Manufacturing B.V. NL-AR-000006691

Other devices from Sion Biotext Medical Ltd

See all devices from Sion Biotext Medical Ltd →

Properties

  • 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