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TANBead Nucleic Acid Extractor

by Taiwan Advanced Nanotech Inc. 9 variants

Ref Maelstrom 9610 (220V)Model Maelstrom 9610

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number471988012M96107U Basic UDI-DI 04719880129454UDI-DIDate2 Nov 2022RegisteredStatusActive

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  • Withdrawn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
TANBead Nucleic Acid Extractor
Model / Reference
Maelstrom 9610, Maelstrom 9610 (220V)
Primary DI / UDI-DI
04719880129454
Basic UDI-DI
471988012M96107U
Direct Marketing DI
04719880129454
EMDN Code
W02050116 Nucleic acid testing integrated extraction /amplification /detection systems
Device Class
Class A
EU market of registration
Germany

Manufacturer details

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

Related devices

Category: Nucleic acid sample preparation instrument IVD

Other devices from Taiwan Advanced Nanotech INC.

See all devices from Taiwan Advanced Nanotech INC. →

Properties

  • Human Tissues
  • Professional Testing
  • Surgical Instrument

Other properties (8)

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