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0101-0002

by Stryker GmbH

Ref 0101-0002Model 08858251002099SX

0101-0002 is a device classified as Class IIb in the EU and Class II in the US made by Stryker GmbH, registered in EUDAMED on 27 Jul 2026 (Basic UDI-DI 08858251002099SX) and listed in FDA GUDID since 22 Dec 2020 (UDI-DI 07613327512175), 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 Number08858251002099SX Basic UDI-DI 07613327512175UDI-DIDate27 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327512175 UDI-DI Date22 Dec 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251002099SX registered 27 Jul 2026 Active
  • FDA GUDID UDI-DI 07613327512175 listed 22 Dec 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327512175
  2. Registered EUDAMED 08858251002099SX

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  • Withdrawn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
Adapt for GAMMA3
Generic name
Medical image management system
Device name
Adapt 2.1 - Software - Class Iib
Model / Ref / Catalog
0101-0002, 08858251002099SX
Primary DI / UDI-DI
07613327512175
Basic UDI-DI
08858251002099SX
FDA product code
OLO
EMDN code
Z12139092 Various orthopaedic and traumatology instruments - medical device software
GMDN term
Medical image management system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.4560
Special device type
Software
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 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: Medical image management system

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Stryker GmbH

See all devices from Stryker GmbH →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)