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Trinity Biotech 30550

by Clark Laboratories, Inc.

Ref 30550

Trinity Biotech 30550 is a device classified as IVD General (EU), Class II (US) made by Clark Laboratories, Inc., registered in EUDAMED on 25 Jul 2026 (Basic UDI-DI B-05391516741545), cleared under FDA 510(k) K930477 on 7 Jun 1993 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 05391516741545), 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) K930477

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-05391516741545 Basic UDI-DI 05391516741545UDI-DIDate25 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05391516741545 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK930477 Date7 Jun 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05391516741545 registered 25 Jul 2026 Active
  • FDA 510(k) K930477 decided 7 Jun 1993 Active
  • FDA GUDID UDI-DI 05391516741545 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K930477
  2. Listed FDA GUDID 05391516741545
  3. Registered EUDAMED B-05391516741545

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  • Withdrawn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 Calibrator 30550 EUDAMED
Trinity Biotech GUDID
Generic name
Angiotensin converting enzyme (ACE) IVD, calibrator
Device name
ACE Calibrator 30550, 6 x 1 mL
Model / Ref / Catalog
30550
Primary DI / UDI-DI
05391516741545
Basic UDI-DI
B-05391516741545
510(k) Number
FDA product code
JIS
EMDN code
W0101050302 Calibrators single component (cc)
GMDN term
Angiotensin converting enzyme (ACE) IVD, calibrator
Device class
Class IVD General EUDAMED
Class II GUDID
Regulation number
862.1150
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 II

Device class is stated on each registry's own scale: Class IVD General 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: Angiotensin converting enzyme (ACE) IVD, calibrator

Cleared under the same submission (K930477)

Similar devices in this category

Other devices filed under CALIBRATORS SINGLE COMPONENT (CC).

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)