Skip to content

LightMix® Newborn TREC/SMN1/HBB

by TIB MOLBIOL Syntheselabor GmbH

Ref 40-0621-IVD

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 linked in EUDAMED

A group certificate may exist

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 Number42601593340-0621-IVD9A Basic UDI-DI 04260159336443UDI-DIDate20 Aug 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

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
40-0621-IVD
Primary DI / UDI-DI
04260159336443
Basic UDI-DI
42601593340-0621-IVD9A
EMDN Code
W010699 Genetic tests - other
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000024382

Other devices from TIB MOLBIOL Syntheselabor GmbH

See all devices from TIB MOLBIOL Syntheselabor GmbH →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (8)

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