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VariAx

by Stryker GmbH

Ref 703918Model 08858251028114U2

VariAx (703918) is a Class I device made by Stryker GmbH, registered in EUDAMED on 3 Aug 2026 (Basic UDI-DI 08858251028114U2) and listed in FDA GUDID since 2 Jun 2026 (UDI-DI 07613327648379), 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 Number08858251028114U2 Basic UDI-DI 07613327648379UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327648379 UDI-DI Date2 Jun 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251028114U2 registered 3 Aug 2026 Active
  • FDA GUDID UDI-DI 07613327648379 listed 2 Jun 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327648379
  2. Registered EUDAMED 08858251028114U2

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  • Withdrawn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 EUDAMED
Pangea GUDID
Generic name
Orthopaedic inorganic implant inserter/extractor, reusable
Device name
Variax 2 Instruments - Torque Limiters - Class I - Non Sterile
Model / Ref / Catalog
08858251028114U2, 703918
Primary DI / UDI-DI
07613327648379
Basic UDI-DI
08858251028114U2
Direct marketing DI
07613327648379
FDA product code
LXH
EMDN code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN term
Orthopaedic inorganic implant inserter/extractor, reusable
Device class
Class I
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

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