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VariAx 45-90001

by Stryker GmbH

Ref 45-90001Model 08858251002949TV

VariAx 45-90001 is a device classified as Class I in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI 08858251002949TV) and listed in FDA GUDID since 23 Jun 2015 (UDI-DI 04546540605412), 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 Number08858251002949TV Basic UDI-DI 04546540605412UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540605412 UDI-DI Date23 Jun 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002949TV registered 24 Sep 2026 Active
  • FDA GUDID UDI-DI 04546540605412 listed 23 Jun 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04546540605412
  2. Registered EUDAMED 08858251002949TV

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  • Withdrawn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
Surgical implant template, reusable
Device name
Variax Instruments - X-Ray Templates - Class I - Non Sterile
Model / Ref / Catalog
45-90001, 08858251002949TV
Primary DI / UDI-DI
04546540605412
Basic UDI-DI
08858251002949TV
FDA product code
KTT
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Surgical implant template, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
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 — 300.0 Millimeter
Width — 430.0 Millimeter

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: Surgical implant template, 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

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)