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Alinity m 09N26-001

by Abbott Molecular

Ref 09N26-001

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, self-declared

Class I: no certifier involved

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 Number0884999AMN0926XT Basic UDI-DI 20884999047840UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20884999047840 UDI-DI Date29 Apr 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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 m
Generic Name
Pipette tip
Device Name
Alinity M Pipette Tips and Co-Re Tip Sleeves
Model / Ref / Catalog
09N26-001
Primary DI / UDI-DI
20884999047840 EUDAMED
00884999047846 GUDID
Basic UDI-DI
0884999AMN0926XT
FDA Product Code
OOI
EMDN Code
W0503020202 Pipettes, tips without filter
GMDN Term
Pipette tip
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
862.2570
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20884999047840
GUDID
00884999047846
Device ClassEUDAMED
Class A
GUDID
Class II

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Properties

  • Single Use
  • Professional Testing
  • Lot / Batch Number

Other properties (21)

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