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Nucleic Acid Extraction Kit (Magnetic Bead Method)

by Jiangsu Yu An Biotechnology Co., Ltd.

Model Yu-R03

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697562146YUR03U7 Basic UDI-DIDate2 Aug 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  • Withdrawn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
Nucleic Acid Extraction Kit (Magnetic Bead Method)
Model / Reference
Yu-R03
Primary DI / UDI-DI
06975621460004
Basic UDI-DI
697562146YUR03U7
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000020608
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Nucleic acid extraction/isolation kit IVD

Properties

  • Reagent

Other properties (10)

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