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LightMix®KIT TREC SMA HBB Newborn

by TIB MOLBIOL Syntheselabor GmbH

Ref 40-0621-44

Active European Union

CE IVDD

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/IVDD NumberB-DEMF2438240062144PN Basic UDI-DI D-DEMF2438240062144PNUDI-DIDate8 Sep 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
LightMix® Kit TREC/SMA/HBB Newborn
Model / Reference
40-0621-44
Primary DI / UDI-DI
D-DEMF2438240062144PN
Basic UDI-DI
B-DEMF2438240062144PN
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
DE-MF-000024382

From the manufacturer

Manufacturer's product page: LightMix® Kits

Other devices from TIB MOLBIOL Syntheselabor GmbH

See all devices from TIB MOLBIOL Syntheselabor GmbH →

Properties

  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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