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42200534

by implantcast GmbH

Ref 42200534Model UKNB09OSLINST

42200534 is a device classified as Class I in the EU and Class II in the US made by implantcast GmbH, registered in EUDAMED on 7 Aug 2026 (Basic UDI-DI 4048844UKNB09OSLINSTHZ) and listed in FDA GUDID since 27 Sep 2024 (UDI-DI 04048844137847), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4048844UKNB09OSLINSTHZ Basic UDI-DI 04048844137847UDI-DIDate7 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04048844137847 UDI-DI Date27 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4048844UKNB09OSLINSTHZ registered 7 Aug 2026 Active
  • FDA GUDID UDI-DI 04048844137847 listed 27 Sep 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04048844137847
  2. Registered EUDAMED 4048844UKNB09OSLINSTHZ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic name
Orthopaedic implantation sleeve, reusable
Model / reference
42200534, UKNB09OSLINST
Primary DI / UDI-DI
04048844137847
Basic UDI-DI
4048844UKNB09OSLINSTHZ
Direct marketing DI
04048844137847
FDA product code
JWH
EMDN code
L0922 Orthopaedic surgery guides, reusable
GMDN term
Orthopaedic implantation sleeve, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3560
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic implantation sleeve, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY GUIDES, REUSABLE.

Other devices from implantcast GmbH

See all devices from implantcast GmbH →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Lot / batch number
Other properties (21, all answered No)