Skip to content

Alinity 07P6630

by Abbott Ireland

Part of a family of 7 devices: see the family page

Ref 07P6630

Alinity 07P6630 is a device classified as Class B in the EU and Class I in the US made by Abbott Ireland, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 038074AIP0766LN) and listed in FDA GUDID since 31 Jul 2018 (UDI-DI 00380740121587), 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 Number038074AIP0766LN Basic UDI-DI 00380740121587UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740121587 UDI-DI Date31 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074AIP0766LN registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740121587 listed 31 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740121587
  2. Registered EUDAMED 038074AIP0766LN

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  • Withdrawn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
Alinity
Generic name
Prolactin IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
07P6630
Primary DI / UDI-DI
00380740121587
Basic UDI-DI
038074AIP0766LN
FDA product code
CFT
EMDN code
W0102050108 Prolactin
GMDN term
Prolactin IVD, kit, chemiluminescent immunoassay
Device class
Class B EUDAMED
Class I GUDID
Regulation number
862.1625
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 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.

Related devices

Category: Prolactin IVD, kit, chemiluminescent immunoassay

Similar devices in this category

Other devices filed under PROLACTIN.

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)