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Nucleic acid extraction and purification kit

by Shanghai BioGerm Medical Technology Co., Ltd. 12 variants

Ref IS-TQ-009-96-1Model 96 tests/kit

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDR, withdrawn

Ended

Withdrawn

Date not published (CE IVDR)

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6974677691097JT Basic UDI-DI 06974677691097UDI-DIDate13 Jun 2023RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDR Withdrawn

Specification

EUDAMED

Model / Reference
96 tests/kit, IS-TQ-009-96-1
Primary DI / UDI-DI
06974677691097
Basic UDI-DI
6974677691097JT
EMDN Code
W010699 Genetic tests - other
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000018164
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shanghai BioGerm Medical Technology Co., Ltd.

See all devices from Shanghai BioGerm Medical Technology 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