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Nucleic Acid Extraction Kit - Pack of 5

by Testmate Health SA

Ref 06-001-306

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 Number7649988808506001306LN Basic UDI-DI 76499888085248UDI-DIDate14 Jul 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  • Withdrawn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
Nucleic Acid Extraction Kit - Pack of 5
Model / Reference
06-001-306
Primary DI / UDI-DI
76499888085248
Basic UDI-DI
7649988808506001306LN
Direct Marketing DI
76499888085248
EMDN Code
W05010299 Urine collection devices - other
Device Class
Class A
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000056839
Authorised representative
QbD RepS BV BE-AR-000000040

Properties

  • Professional Testing
  • New Device

Other properties (9)

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