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VitaSIRO solo MT-RNR1 SNP Variant External Control Set

by Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch

Ref PCRAD1171

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-04719878570626 Basic UDI-DI 04719878570626UDI-DIDate22 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  • Withdrawn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
VitaSIRO solo™ MT-RNR1 SNP Variant External Control Set
Model / Reference
PCRAD1171
Primary DI / UDI-DI
04719878570626
Basic UDI-DI
B-04719878570626
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
TW-MF-000023414
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No