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Beiwo

by Hangzhou Beiwo Medical Technology Co., Ltd. 6 variants

Ref BW-MGD2318-A32Model BW-MGD2318-A32 BW-MGD2318-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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697557396bwyx003MD Basic UDI-DI 06975573960034UDI-DIDate4 Jul 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  • Withdrawn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
Saliva gDNA Isolation Kit (Beads)
Model / Reference
BW-MGD2318-A32 BW-MGD2318-A96, BW-MGD2318-A32
Primary DI / UDI-DI
06975573960034
Basic UDI-DI
697557396bwyx003MD
Direct Marketing DI
06975573960034
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A
EU market of registration
Austria

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.

See all devices from Hangzhou Beiwo Medical Technology Co., Ltd. →

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