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DNA Methylation Conversion Kit (Column Test)

by Shenzhen Sciarray Biotech Co., Ltd. China EUDAMED

Ref 100 tests/ kitModel 20 tests/ kit, 40 tests/ kit, 100 tests/kit, 200 tests/kit

EMDN W01019099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697549176DMCTSK Basic UDI-DIDate24 Oct 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
DNA Methylation Conversion Kit (Column Test)
Model / Reference
20 tests/ kit, 40 tests/ kit, 100 tests/kit, 200 tests/kit, 100 tests/ kit
Primary DI / UDI-DI
06975491760136
Basic UDI-DI
697549176DMCTSK
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000038307
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Nucleic acid extraction/isolation kit IVD

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Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 9cd344ea-4c0c-4b3e-92a7-e70983a7cbd8 61 fields · synced 22 Oct 2026