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MagPure Circulating DNA Kit

by Xiamen Zhixuan Biotech Co., Ltd 3 variants

Ref ZEC601-T96(96rxns)Model ZEC601（480rxns）、ZEC601-T48(96rxns)、ZEC601-T96(96rxns)

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 Number697551622ZXMCDK2B Basic UDI-DI 06975516220065UDI-DIDate20 Apr 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  • Withdrawn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
MagPure Circulating DNA Kit
Model / Reference
ZEC601（480rxns）、ZEC601-T48(96rxns)、ZEC601-T96(96rxns), ZEC601-T96(96rxns)
Primary DI / UDI-DI
06975516220065
Basic UDI-DI
697551622ZXMCDK2B
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000027993
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Other devices from Xiamen Zhixuan Biotech Co., Ltd

See all devices from Xiamen Zhixuan Biotech 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