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Liofilchem Antibiotic Disc Gepotidacin GEP 10 µg

by Liofilchem, Inc.

Ref 9256/1

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number805518287ATBDISC256Z9 Basic UDI-DI 08056138338937UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056138338937 UDI-DI Date7 Aug 2026ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
Liofilchem Antibiotic Disc
Generic Name
Antibacterial susceptibility testing disc IVD
Device Name
Gepotidacin GEP 10 µg
Model / Reference
9256/1 EUDAMED
Gepotidacin GEP 10 µg GUDID
Primary DI / UDI-DI
08056138338937
Basic UDI-DI
805518287ATBDISC256Z9
510(k) Number
FDA Product Code
JWY
EMDN Code
W0104080502 Impregnated disks, multi-disks & tablets
GMDN Term
Antibacterial susceptibility testing disc IVD
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
866.1640
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
9256/1
GUDID
Gepotidacin GEP 10 µg
Device ClassEUDAMED
Class B
GUDID
Class II

Related devices

Cleared under the same submission (K261853)

Other devices from Liofilchem, Inc.

See all devices from Liofilchem, Inc. →

Properties

  • Single Use
  • Professional Testing
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • 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
  • Manufacturing Date: No