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MycoMDx Aspergillus Cartridge PCR Assay

by Dynamiker Biotechnology (Tianjin) Co., Ltd. 2 variants

Ref DNK-2601-2Model 48 tests/kit

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06930317806702 Basic UDI-DI 06930317806702UDI-DIDate5 Mar 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  • Withdrawn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
MycoMDx Aspergillus Cartridge PCR Assay
Model / Reference
48 tests/kit, DNK-2601-2
Primary DI / UDI-DI
06930317806702
Basic UDI-DI
B-06930317806702
EMDN Code
W0105060401 Aspergillus - na reagents
Device Class
Class IVD General
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000001133
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

Other devices from Dynamiker Biotechnology (Tianjin) Co., Ltd.

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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