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Variax 622104S

by Stryker Corp.

Ref 622104SModel 08858251004431SX

Variax 622104S is a device classified as Class IIb in the EU and Class II in the US made by Stryker Corp., registered in EUDAMED on 28 Jul 2026 (Basic UDI-DI 08858251004431SX) and listed in FDA GUDID since 7 Nov 2022 (UDI-DI 07613327347562), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251004431SX Basic UDI-DI 07613327347562UDI-DIDate28 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327347562 UDI-DI Date7 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251004431SX registered 28 Jul 2026 Active
  • FDA GUDID UDI-DI 07613327347562 listed 7 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327347562
  2. Registered EUDAMED 08858251004431SX

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  • Withdrawn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® 2 EUDAMED
Variax GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Variax 2 Mis Calcaneus - Plate - Titanium - Class Iib - Sterile
Model / Ref / Catalog
622104S, 08858251004431SX
Primary DI / UDI-DI
07613327347562
Basic UDI-DI
08858251004431SX
FDA product code
HRS
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Orthopaedic fixation plate, non-bioabsorbable

Similar devices in this category

Other devices filed under BONE FIXATION PLATES.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)