Skip to content

Alinity

by ABBOTT GmbH 2 variants

Ref 09P2611

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 Number038074AIP0926LL Basic UDI-DI 00380740189839UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740189839 UDI-DI Date1 Jan 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  • Withdrawn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
Vitamin B12 IVD, control
Model / Ref / Catalog
09P2611
Primary DI / UDI-DI
00380740189839
Basic UDI-DI
038074AIP0926LL
FDA Product Code
JJX
EMDN Code
W0102152099 Controls- immunochemistry - other
GMDN Term
Vitamin B12 IVD, control
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
862.1660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000009455

Other devices from ABBOTT GmbH

See all devices from ABBOTT GmbH →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human 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
  • Serial Number: No
  • Manufacturing Date: No