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Remotion 300-3500

by Stryker GmbH

Ref 300-3500Model 08858251003039SL

Remotion 300-3500 is a device classified as Class IIa in the EU and Class I in the US made by Stryker GmbH, registered in EUDAMED on 18 Aug 2026 (Basic UDI-DI 08858251003039SL) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00886385014944), active as of 12 Nov 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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003039SL Basic UDI-DI 00886385014944UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00886385014944 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003039SL registered 18 Aug 2026 Active
  • FDA GUDID UDI-DI 00886385014944 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00886385014944
  2. Registered EUDAMED 08858251003039SL

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  • Withdrawn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
Re-Motion EUDAMED
Remotion GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Re-Motion Instruments - Guide-Wires, K-Wires, Pins - Class Iia - Non Sterile
Model / Ref / Catalog
300-3500, 08858251003039SL
Primary DI / UDI-DI
00886385014944
Basic UDI-DI
08858251003039SL
FDA product code
LXH
EMDN code
P090380 Wrist prostheses - accessories
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 140.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)