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Alinity 08P2210

by Abbott Laboratories

Ref 08P2210

Alinity 08P2210 is a device classified as Class C in the EU and Class I in the US made by Abbott Laboratories, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 805805668CIAMMO02ZZ018NR4) and listed in FDA GUDID since 30 Jul 2018 (UDI-DI 00380740136185), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number805805668CIAMMO02ZZ018NR4 Basic UDI-DI 00380740136185UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740136185 UDI-DI Date30 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805805668CIAMMO02ZZ018NR4 registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 00380740136185 listed 30 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740136185
  2. Registered EUDAMED 805805668CIAMMO02ZZ018NR4

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  • Withdrawn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 c Ammonia Controls EUDAMED
Alinity GUDID
Generic name
Ammonia IVD, control
Device name
Ammonia 2
Model / Ref / Catalog
08P2210
Primary DI / UDI-DI
00380740136185
Basic UDI-DI
805805668CIAMMO02ZZ018NR4
FDA product code
JJX
EMDN code
W0101050204 Electrolyte controls
GMDN term
Ammonia IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Standard device
EU market of registration
Italy
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: Ammonia IVD, control

Similar devices in this category

Other devices filed under ELECTROLYTE CONTROLS.

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)