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Variax 45-35015S

by Stryker GmbH

Ref 45-35015SModel 08858251003089T3

Variax 45-35015S is a device classified as Class IIa in the EU and Class I in the US made by Stryker GmbH, registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI 08858251003089T3) and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 07613154969357), 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 Number08858251003089T3 Basic UDI-DI 07613154969357UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613154969357 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003089T3 registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 07613154969357 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613154969357
  2. Registered EUDAMED 08858251003089T3

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  • Withdrawn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
Variax
Generic name
Instrument tray, reusable
Device name
Variax Instruments - Screwdrivers and Tightening Instrumentation - Class Iia - Sterile
Model / Ref / Catalog
45-35015S, 08858251003089T3
Primary DI / UDI-DI
07613154969357
Basic UDI-DI
08858251003089T3
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Instrument tray, 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

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: Instrument tray, reusable

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Supplied sterile
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)