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TANBead Nucleic Acid Extraction Kit

by Taiwan Advanced Nanotech Inc. EUDAMEDGUDID

Active European Union

Ref M61ES46-NXModel 61E series

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04719880123919 UDI-DIDate7 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number47198801261EH7 Basic UDI-DIDate16 Dec 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Nucleic acid extraction/isolation kit IVD
Model / Reference
61E series, M61ES46-NX
Primary DI / UDI-DI
04719880123919
Basic UDI-DI
47198801261EH7
FDA Product Code
JJH
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
GMDN Term
Nucleic acid extraction/isolation kit IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2310
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

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

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Other devices from Taiwan Advanced Nanotech INC.

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Properties

  • Single Use
  • Contains Latex
  • Human Tissues
  • Reagent
  • Professional Testing
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • Sterile: No
  • Implantable: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No