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OP-FIX mit HAKEN

by GERWING Medizinprodukte Gerd Riester e.K.

Ref GE 03-1006 R, GE 03-1006 WRModel Universal-Schlauchhalter

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number426046972GE0378 Basic UDI-DI Date21 Oct 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
OP-FIX mit CLIP
Model / Reference
Universal-Schlauchhalter, GE 03-1006 R, GE 03-1006 WR
Primary DI / UDI-DI
04260469720581, 04260469720598
Basic UDI-DI
426046972GE0378
Direct Marketing DI
04260469720581
04260469720598
EMDN Code
V80 Clinical use accessories not included in other classes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006156

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No