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Nucleic Acid Extractor

by Singuway Biotech Inc. 3 variants

Ref 043, 029Model Singu20, Singu32

Nucleic Acid Extractor (043) is an in vitro diagnostic device (EU IVDR Class A; EMDN category various sample processing instruments) made by Singuway Biotech Inc., registered in EUDAMED on 2 Jun 2023 (Basic UDI-DI 697408187Singu204P), active as of 22 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697408187Singu204P Basic UDI-DI Date2 Jun 2023RegisteredStatusActive

Official records

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  • Withdrawn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

Model / reference
Singu20, 043, Singu32, 029
Primary DI / UDI-DI
06974081870248, 06974081870293
Basic UDI-DI
697408187Singu204P, 697408187Singu324W
Direct marketing DI
06974081870248
06974081870293
EMDN code
W02069099 Various sample processing instruments - other
Device class
Class A
EU registration type
Standard device
EU market of registration
France
Spain

Manufacturer details

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

Similar devices in this category

Other devices filed under VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER.

Other devices from Singuway Biotech Inc.

See all devices from Singuway Biotech Inc. →

Properties

  • Professional testing
  • IVD instrument
Other properties (11, all answered No)