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Swab Transport Medium (Modified Lysis buffer)

by Tellgen Corporation

Ref PFA4X042Model 48 Bottles/Kit

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697299500IVD015PJ Basic UDI-DI 06980112314803UDI-DIDate27 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Swab Transport Medium (Modified Lysis buffer)
Model / Reference
48 Bottles/Kit, PFA4X042
Primary DI / UDI-DI
06980112314803
Basic UDI-DI
697299500IVD015PJ
EMDN Code
W05020199 Samples transport, containers - other
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000013143
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No