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DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR)

by Envelope Health Biotechnology Co., Ltd. 2 variants

Ref EH001C-200 200 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Withdrawn Withdrawn in European Union.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Was authorized under CE IVDR, withdrawn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Withdrawn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 linked in EUDAMED

A group certificate may exist

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 Number697464392METH01RW Basic UDI-DI 06974643920145UDI-DIDate11 Sep 2023RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Withdrawn

Specification

EUDAMED

Model / Reference
EH001C-200 200 tests/kit
Primary DI / UDI-DI
06974643920145
Basic UDI-DI
697464392METH01RW
EMDN Code
W010699 Genetic tests - other
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015645
Authorised representative
MedPath GmbH DE-AR-000000087

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