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Nucleic acid extraction kit

by Hangzhou MiYin Biotechnology Co., Ltd

Ref TQ-XJ-MR-032, TQ-XQ-R-032, TQ-XJ-D-032Model TQ-XJ-D-032 ；TQ-XQ-R-032

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697533032MYNAEKRF Basic UDI-DI Date13 May 2024RegisteredStatusActive

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  • Withdrawn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
Model / Reference
TQ-XJ-D-032 ；TQ-XQ-R-032, TQ-XJ-MR-032, TQ-XQ-R-032, TQ-XJ-D-032
Primary DI / UDI-DI
06975330320064, 06975330320040, 06975330320033
Basic UDI-DI
697533032MYNAEKRF
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000041649
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou MiYin Biotechnology Co., Ltd

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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