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Protein S Ac 10445968

by Siemens Healthcare Diagnostics Products Ltd

Ref 10445968Model IVDR_27_MAR EB_C_KIT_Prot_S_Ac

Protein S Ac 10445968 (OPAP03) is a device classified as Class C in the EU and Class II in the US made by Siemens Healthcare Diagnostics Products Ltd, registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 0405686900968WJ), cleared under FDA 510(k) K022290 on 27 Aug 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00842768006678), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K022290

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686900968WJ Basic UDI-DI 00842768006678UDI-DIDate15 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842768006678 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK022290 Date27 Aug 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686900968WJ registered 15 Jun 2026 Active
  • FDA 510(k) K022290 decided 27 Aug 2002 Active
  • FDA GUDID UDI-DI 00842768006678 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K022290
  2. Listed FDA GUDID 00842768006678
  3. Registered EUDAMED 0405686900968WJ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Protein S Ac
Generic name
Protein S IVD, kit, clotting
Device name
IVDR_27_MAR EB_C_KIT_Prot_S_Ac
Model / Ref / Catalog
10445968, IVDR_27_MAR EB_C_KIT_Prot_S_Ac, OPAP03
Primary DI / UDI-DI
00842768006678
Basic UDI-DI
0405686900968WJ
510(k) Number
FDA product code
GGP
EMDN code
W0103020608 Protein s activity
GMDN term
Protein S IVD, kit, clotting
Device class
Class C EUDAMED
Class II GUDID
Regulation number
864.7290
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class II

Device class is stated on each registry's own scale: Class C 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: Protein S IVD, kit, clotting

Cleared under the same submission (K022290)

Similar devices in this category

Other devices filed under COAGULATION INHIBITORS/THROMBOPHILIA MARKERS.

Other devices from Siemens Healthcare Diagnostics Products Ltd

See all devices from Siemens Healthcare Diagnostics Products Ltd →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)