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Alinity m 09R20-002

by Abbott Molecular

Ref 09R20-002

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

CE MDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00884999051744 UDI-DI Date6 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0884999YZR0920JX Basic UDI-DI 00884999051744UDI-DIDate2 Jul 2026RegisteredStatusActive

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Alinity m
Generic Name
General-purpose absorbent tip applicator/swab, single-use
Model / Ref / Catalog
09R20-002
Primary DI / UDI-DI
00884999051744
Basic UDI-DI
0884999YZR0920JX
FDA Product Code
KXG
EMDN Code
A1101 Sample collection neutral swabs
GMDN Term
General-purpose absorbent tip applicator/swab, single-use
Device Class
Class I
Regulation Number
880.6025
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

  • Sterile
  • Single Use
  • Combination Product
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No