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Automatic Nucleic Acid Amplification Detection Analyzer

by Nanjing RainGene Biotechnology Co., Ltd.

Ref 030101CBModel SmartRangerⅡ, SmartRangeⅣ, SmartRangeⅧ

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697517839AutoNAADAQ2 Basic UDI-DI 06975178390038UDI-DIDate14 Oct 2022RegisteredStatusActive EUDAMED: not 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  • Withdrawn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 Active

Specification

EUDAMED

Model / Reference
SmartRangerⅡ, SmartRangeⅣ, SmartRangeⅧ, 030101CB
Primary DI / UDI-DI
06975178390038
Basic UDI-DI
697517839AutoNAADAQ2
EMDN Code
W02050116, W02050199
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000023111
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No