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Cardiac Marker Complete Level 2 91482

by Cliniqa Corporation

Ref 91482

Cardiac Marker Complete Level 2 91482 is a device classified as IVD General (EU), Class I (US) made by Cliniqa Corporation, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-00817238010066), cleared under FDA 510(k) K080973 on 2 Jun 2008 and listed in FDA GUDID since 22 Aug 2018 (UDI-DI 00817238010066), active as of 8 Nov 2026.

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

CE IVDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K080973

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00817238010066 Basic UDI-DI 00817238010066UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817238010066 UDI-DI Date22 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK080973 Date2 Jun 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00817238010066 registered 26 Oct 2026 Active
  • FDA 510(k) K080973 decided 2 Jun 2008 Active
  • FDA GUDID UDI-DI 00817238010066 listed 22 Aug 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K080973
  2. Listed FDA GUDID 00817238010066
  3. Registered EUDAMED B-00817238010066

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Cardiac Marker Control Complete + TnT EUDAMED
Cardiac Marker Complete Level 2 GUDID
Generic name
Multiple cardiac marker IVD, control
Device name
Cardiac Marker Control Complete + TnI Level 2
Model / reference
91482
Description
Cardiac Marker Control +TnI Level 2
Primary DI / UDI-DI
00817238010066
Basic UDI-DI
B-00817238010066
510(k) Number
FDA product code
JJY
EMDN code
W0102152004 Cardiac marker controls
GMDN term
Multiple cardiac marker IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General 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: Multiple cardiac marker IVD, control

Cleared under the same submission (K080973)

and 6 more cleared under K080973

Similar devices in this category

Other devices filed under CARDIAC MARKER CONTROLS.

Other devices from Cliniqa Corporation

See all devices from Cliniqa Corporation →

Properties

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