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TANBead Nucleic Acid Extraction Kit

by Taiwan Advanced Nanotech Inc. EUDAMED

Active European Union

Ref 61FS46Model 61F series

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number47198801261FH9 Basic UDI-DIDate20 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
TANBead Nucleic Acid Extraction Kit
Model / Reference
61F series, 61FS46
Primary DI / UDI-DI
04719880121618
Basic UDI-DI
47198801261FH9
Direct Marketing DI
04719880121618
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000019040
Authorised representative
mdi Europa GmbH DE-AR-000006218

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Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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