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Orientable Alignment Guide - Lateral 20°/45°

by Incipio Devices SA

Ref SSI006236

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7630055300503401OAG8F Basic UDI-DI 07630055303189UDI-DIDate16 Apr 2025RegisteredStatusActive

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  • Withdrawn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
Orientable Alignment Guide
Model / Reference
SSI006236
Primary DI / UDI-DI
07630055303189
Basic UDI-DI
7630055300503401OAG8F
Direct Marketing DI
07630055303189
EMDN Code
L0922 Orthopaedic surgery guides, reusable
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CH-MF-000030518
Authorised representative
MDSS GmbH DE-AR-000005430

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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