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CAT00241

by Stryker Corp.

Ref CAT00241Model 08858251003420SK

CAT00241 is a device classified as Class IIa in the EU and Class I in the US made by Stryker Corp., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 08858251003420SK) and listed in FDA GUDID since 4 Sep 2015 (UDI-DI 07613252632863), active as of 7 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003420SK Basic UDI-DI 07613252632863UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613252632863 UDI-DI Date4 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251003420SK registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 07613252632863 listed 4 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613252632863
  2. Registered EUDAMED 08858251003420SK

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  • Withdrawn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

Generic name
Orthopaedic surgical procedure kit, non-medicated, single-use
Device name
SMBU_TF10452_Portal Entry Kit
Model / Ref / Catalog
CAT00241, 08858251003420SK
Primary DI / UDI-DI
07613252632863
Basic UDI-DI
08858251003420SK
FDA product code
KDD
EMDN code
K030299 Arthroscopy surgical instruments, single use - other
GMDN term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Ireland
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: Orthopaedic surgical procedure kit, non-medicated, single-use

Similar devices in this category

Other devices filed under ARTHROSCOPY SURGICAL INSTRUMENTS, SINGLE USE - OTHER.

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)