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Nucleic Acid Extraction or Purification Reagent

by Jiangsu Comeon Medical Apparatus Co., Ltd 2 variants

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697563134KM007G4 Basic UDI-DI 16975631347019UDI-DIDate10 Jan 2023RegisteredStatusActive

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  • Withdrawn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 or Purification Reagent
Primary DI / UDI-DI
16975631347019
Basic UDI-DI
697563134KM007G4
EMDN Code
W0104080601, W0104080602, W0104080604, W0104080605, W0104080606, W0104080607, W0104080699
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000018384
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Jiangsu Comeon Medical Apparatus Co., Ltd

See all devices from Jiangsu Comeon Medical Apparatus 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