Skip to content

No brand

by Hangzhou Aokai Biotech Co., Ltd. 10 variants

Ref M-401-0014Model M-401

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 Number697846791M40100001PJ Basic UDI-DI 06978467910085UDI-DIDate9 Sep 2026RegisteredStatusActive

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  • Withdrawn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
4 in 1 Multi-Parameter Monitoring System II
Model / Reference
M-401, M-401-0014
Primary DI / UDI-DI
06978467910085
Basic UDI-DI
697846791M40100001PJ
Direct Marketing DI
06978467910085
EMDN Code
W020106019099 Various diabetes monitoring instruments - other
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000048311
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

Other devices from Hangzhou Aokai Biotech Co., Ltd.

See all devices from Hangzhou Aokai Biotech Co., Ltd. →

Properties

  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No