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Hoffmann

by Stryker GmbH 54 variants

Ref 4938-1-155Model 08858251002865TN

Hoffmann (4938-1-155) is a Class I device made by Stryker GmbH, registered in EUDAMED on 14 Jul 2026 (Basic UDI-DI 08858251002865TN) and listed in FDA GUDID since 15 Jul 2026 (UDI-DI 07613327617535), 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
United StatesGUDID listing GUDID Number07613327617535 UDI-DI Date15 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08858251002865TN Basic UDI-DI 07613327617535UDI-DIDate14 Jul 2026RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002865TN registered 14 Jul 2026 Active
  • FDA GUDID UDI-DI 07613327617535 listed 15 Jul 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 08858251002865TN
  2. Listed FDA GUDID 07613327617535

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  • Withdrawn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

Trade name
Hoffmann EUDAMED
Hoffmann Lrf GUDID
Generic name
External orthopaedic fixation system noninvasive component template
Device name
Hlrf - Sizing and Scaling Instrumentation - Class I - Non Sterile
Model / Ref / Catalog
08858251002865TN, 4938-1-155
Primary DI / UDI-DI
07613327617535
Basic UDI-DI
08858251002865TN
Direct marketing DI
07613327617535
FDA product code
HWT
EMDN code
P09120499 External bone fixation systems - other
GMDN term
External orthopaedic fixation system noninvasive component template
Device class
Class I
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Manufacturer details

EUDAMED SRN
CH-MF-000009332
Authorised representative
Stryker European Operations Limited IE-AR-000000092

Similar devices in this category

Other devices filed under EXTERNAL BONE FIXATION SYSTEMS - OTHER.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)