Skip to content

Architect 08K4112

by Abbott

Ref 08K4112

Architect 08K4112 is a device classified as Class C in the EU and Class I in the US made by Abbott, registered in EUDAMED on 23 Aug 2026 (Basic UDI-DI 038074ARK0841N9) and listed in FDA GUDID since 22 Nov 2019 (UDI-DI 00380740169817), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARK0841N9 Basic UDI-DI 00380740169817UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740169817 UDI-DI Date22 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074ARK0841N9 registered 23 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740169817 listed 22 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740169817
  2. Registered EUDAMED 038074ARK0841N9

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Architect
Generic name
Insulin IVD, control
Device name
ARCHITECT Insulin
Model / Ref / Catalog
08K4112
Primary DI / UDI-DI
00380740169817
Basic UDI-DI
038074ARK0841N9
FDA product code
JJX
EMDN code
W0102152002 Hormone controls
GMDN term
Insulin IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660
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 I

Device class is stated on each registry's own scale: Class C 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: Insulin IVD, control

Similar devices in this category

Other devices filed under HORMONE CONTROLS.

Other devices from Abbott

See all devices from Abbott →

Properties

  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)