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Pathogen DNA/RNA Purification Kit (Beads)

by Hangzhou Beiwo Medical Technology Co., Ltd.

Ref BW-MGD2411-A32-32Model BW-MGD2411-A00 BW-MGD2411-A32 BW-MGD2411-A32-32 BW-MGD2411-A96

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 Number697557396bwyx007MM Basic UDI-DI 06975573960133UDI-DIDate10 Aug 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  • Withdrawn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

Model / Reference
BW-MGD2411-A00 BW-MGD2411-A32 BW-MGD2411-A32-32 BW-MGD2411-A96, BW-MGD2411-A32-32
Primary DI / UDI-DI
06975573960133
Basic UDI-DI
697557396bwyx007MM
Direct Marketing DI
06975573960133
EMDN Code
W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000027312
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Beiwo Medical Technology Co., Ltd.

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Properties

  • Reagent
  • Professional Testing
  • Companion Diagnostics

Other properties (8)

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