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Lyfo Disk™ 0626l

by Microbiologics, Inc.

Ref [0626L] LYFO DISK™ K. oxytoca ATCC 49131™Model 0626

Lyfo Disk™ 0626l is a device classified as Class B in the EU and Class I in the US made by Microbiologics, Inc., registered in EUDAMED on 20 Apr 2026 (Basic UDI-DI 084535700626A4) and listed in FDA GUDID since 30 Apr 2020 (UDI-DI 10845357014792), 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 Number084535700626A4 Basic UDI-DI 10845357014792UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10845357014792 UDI-DI Date30 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 084535700626A4 registered 20 Apr 2026 Active
  • FDA GUDID UDI-DI 10845357014792 listed 30 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10845357014792
  2. Registered EUDAMED 084535700626A4

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  • Withdrawn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
Lyfo Disk™
Generic name
Multiple bacteria species culture isolate identification control IVD, kit
Device name
KWIK-STIK™ and LYFO DISK™
Model / Ref / Catalog
0626 EUDAMED
[0626L] LYFO DISK™ K. oxytoca ATCC 49131™ EUDAMED
0626L GUDID
Primary DI / UDI-DI
10845357014792
Basic UDI-DI
084535700626A4
FDA product code
JTR
EMDN code
W01040601 Qc strains bacteriology
GMDN term
Multiple bacteria species culture isolate identification control IVD, kit
Device class
Class B EUDAMED
Class I GUDID
Regulation number
866.2480
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0626
[0626L] LYFO DISK™ K. oxytoca ATCC 49131™
GUDID
0626L
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.

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Properties

  • Single use
  • Contains substances of microbial origin
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)