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Mycobacterium Tuberculosis Nucleic Acid Assay Control

by Guangzhou Pluslife Biotech Co., Ltd

Ref CRM1010602-5

Active European Union

CE IVDR

Valid until

18 Sep 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Kiwa Sertio Oy

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 Number697532712CRM1010602AG Basic UDI-DI 06975327121315UDI-DIDate27 Sep 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EU-TDA-FI-34440-800076-2026 Active

    Technical documentation EU IVDR

    Certifier
    Kiwa Sertio Oy 3018
    Issued
    18 Sep 2026
    Expires
    18 Sep 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Mycobacterium Tuberculosis Nucleic Acid Assay Control
Model / Reference
CRM1010602-5
Primary DI / UDI-DI
06975327121315
Basic UDI-DI
697532712CRM1010602AG
Unit of Use DI
86975327121311
EMDN Code
W0105094001 Controls infectious immunology - rt & poc
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025784
Authorised representative
Medunion S.L. ES-AR-000019366

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Properties

  • Human Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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