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Trinity Biotech A6040

by Clark Laboratories, Inc.

Ref A6040

Trinity Biotech A6040 is a device classified as IVD General (EU), Class I (US) made by Clark Laboratories, Inc., registered in EUDAMED on 25 Jul 2026 (Basic UDI-DI B-05391516747233), cleared under FDA 510(k) K860453 on 19 Feb 1986 and listed in FDA GUDID since 7 May 2017 (UDI-DI 05391516747233), active as of 25 Oct 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K860453

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/IVDD EUDAMED NumberB-05391516747233 Basic UDI-DI 05391516747233UDI-DIDate25 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05391516747233 UDI-DI Date7 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK860453 Date19 Feb 1986DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05391516747233 registered 25 Jul 2026 Active
  • FDA 510(k) K860453 decided 19 Feb 1986 Active
  • FDA GUDID UDI-DI 05391516747233 listed 7 May 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K860453
  2. Listed FDA GUDID 05391516747233
  3. Registered EUDAMED B-05391516747233

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  • Withdrawn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
ACE Control-N EUDAMED
Trinity Biotech GUDID
Generic name
Angiotensin converting enzyme (ACE) IVD, control
Model / Ref / Catalog
A6040
Primary DI / UDI-DI
05391516747233
Basic UDI-DI
B-05391516747233
510(k) Number
FDA product code
JJX
EMDN code
W0101050201 Enzyme controls
GMDN term
Angiotensin converting enzyme (ACE) 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: Angiotensin converting enzyme (ACE) IVD, control

Cleared under the same submission (K860453)

Similar devices in this category

Other devices filed under ENZYME CONTROLS.

Other devices from Clark Laboratories, Inc.

See all devices from Clark Laboratories, Inc. →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)