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Automated NGS Library Prep System

by 3D Biomedicine Science & Technology Co., Limited

Ref 3000000000390Model ANDiS 500

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 Number697368547805QT Basic UDI-DI 06973685478553UDI-DIDate15 Sep 2026RegisteredStatusActive

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  • Withdrawn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
Automated NGS Library Prep System
Model / Reference
ANDiS 500, 3000000000390
Primary DI / UDI-DI
06973685478553
Basic UDI-DI
697368547805QT
Direct Marketing DI
06973685478553
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000020934
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from 3D Biomedicine Science & Technology Co., Limited

See all devices from 3D Biomedicine Science & Technology Co., Limited →

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