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Architect

by ABBOTT GmbH 2 variants

Ref 04P5222

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

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARP0452PH Basic UDI-DI 00380740208622UDI-DIDate23 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740208622 UDI-DI Date15 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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

Generic Name
Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry
Device Name
ARCHITECT Hemoglobin A1c
Model / Ref / Catalog
04P5222, 4P52-22
Primary DI / UDI-DI
00380740208622
Basic UDI-DI
038074ARP0452PH
FDA Product Code
PDJ, LCP
EMDN Code
W01010214 Glycosylated/glycated haemoglobin (cc)
GMDN Term
Glycated haemoglobin (HbA1c) IVD, kit, spectrophotometry
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.1373, 864.7470
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
04P5222
GUDID
4P52-22
Device ClassEUDAMED
Class C
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000009455

Other devices from ABBOTT GmbH

See all devices from ABBOTT GmbH →

Properties

  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No