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Automated Nucleic Acid Extractor

by Bifour Biotech Inc.

Ref NAE 2 PLUS

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 Number08600102462NucleicAcidVQ Basic UDI-DI 00860010246221UDI-DIDate19 Mar 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  • Withdrawn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 Nucleic Acid Extractor
Model / Reference
NAE 2 PLUS
Primary DI / UDI-DI
00860010246221
Basic UDI-DI
08600102462NucleicAcidVQ
EMDN Code
W02050199 Nucleic acid testing instruments except micro-arrays - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000034957
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Bifour Biotech Inc.

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