Skip to content

Guide Pin

by ORTHOTECH Co., Ltd 9 variants

Ref IG42-18

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 Number88000453BEOTI001KA Basic UDI-DI 08800045327337UDI-DIDate28 Aug 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  • Withdrawn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
Orthopaedic Instrument
Model / Reference
IG42-18
Primary DI / UDI-DI
08800045327337
Basic UDI-DI
88000453BEOTI001KA
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000048890
Authorised representative
AF Pharma Service Europe SL ES-AR-000018076

Other devices from ORTHOTECH Co., Ltd

See all devices from ORTHOTECH Co., Ltd →

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