Architect 7K62-25 07K6225: CE/IVDR Class B, Abbott Ireland

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR EUDAMED	Number038074ARK0762NC Basic UDI-DI 00380740014230UDI-DI	Date17 Aug 2026Registered	StatusActive
United States	GUDID listing GUDID	Number00380740014230 UDI-DI	Date9 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Official records

EUDAMED public site Basic UDI-DI 038074ARK0762NC — open Devices and search for it
AccessGUDID record UDI-DI 00380740014230

Across registries

2 registries list this device

EUDAMED Basic UDI-DI 038074ARK0762NC registered 17 Aug 2026 Active
FDA GUDID UDI-DI 00380740014230 listed 9 Sep 2016 Listed

Timeline

2 dated events

9 Sep 2016 Listed FDA GUDID 00380740014230
17 Aug 2026 Registered EUDAMED 038074ARK0762NC

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/IVDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name: Architect
Generic name: Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Device name: Architect TSH
Model / Ref / Catalog: 07K6225, 7K62-25

Primary DI / UDI-DI: 00380740014230
Basic UDI-DI: 038074ARK0762NC
FDA product code: JJX, JLW, JIT
EMDN code: W01020410 Thyroid stimulating hormone
GMDN term: Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

Device class: Class B EUDAMED
Class I GUDID
Regulation number: 862.1660, 862.1690, 862.1150
EU registration type: Standard device
EU market of registration: Ireland
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED 07K6225	GUDID 7K62-25
Device class	EUDAMED Class B	GUDID Class I

Device class is stated on each registry's own scale: Class B in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.