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Nucleic Acid Extraction Reagents(Magnetic Bead)

by Singuway Biotech Inc. 8 variants

Ref MTQ036Model TM-36

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 Number697408187R044JD Basic UDI-DI 06974081870323UDI-DIDate2 Jun 2023RegisteredStatusActive

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  • Withdrawn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
Nucleic Acid Extraction Reagents (Magnetic Bead)
Model / Reference
TM-36, MTQ036
Primary DI / UDI-DI
06974081870323
Basic UDI-DI
697408187R044JD
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000027180
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Other devices from Singuway Biotech Inc.

See all devices from Singuway Biotech Inc. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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