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Nucleic Acid Extraction Reagent

by Jiangsu Qitian Gene biotechnology Co., Ltd 12 variants

Ref LZD001-32JⅠModel V1-D/R-64JⅠ

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697510244LZD001FP Basic UDI-DI 06975102440228UDI-DIDate15 Dec 2025RegisteredStatusActive

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  • Withdrawn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 Reagent
Model / Reference
V1-D/R-64JⅠ, LZD001-32JⅠ
Primary DI / UDI-DI
06975102440228
Basic UDI-DI
697510244LZD001FP
Direct Marketing DI
06975102440228
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000050877
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Other devices from Jiangsu Qitian Gene biotechnology Co., Ltd

See all devices from Jiangsu Qitian Gene 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