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Nucleic Acid Extraction and Methylation Conversion Kit

by Shenzhen Sciarray Biotech Co., Ltd. 5 variants

Ref 8 tests/ kitModel 8 tests/ kit, 16 tests/ kit, 32 tests/ kit, 48 tests/ kit, 96 tests/ kit

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 linked in EUDAMED

A group certificate may exist

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 Number697549176NAEAMCK3C Basic UDI-DI 06975491760068UDI-DIDate24 Oct 2023RegisteredStatusActive

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  • Withdrawn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 Active

Specification

EUDAMED

Device Name
Nucleic Acid Extraction and Methylation Conversion Kit
Model / Reference
8 tests/ kit, 16 tests/ kit, 32 tests/ kit, 48 tests/ kit, 96 tests/ kit
Primary DI / UDI-DI
06975491760068
Basic UDI-DI
697549176NAEAMCK3C
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

Other devices from Shenzhen Sciarray Biotech Co., Ltd.

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Properties

  • Sterile
  • Reagent
  • Professional Testing

Other properties (8)

  • 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