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by Hangzhou Aokai Biotech Co., Ltd. 10 variants

Ref M-601-0014Model M-601

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697846791M-60100001X5 Basic UDI-DI 06978467910986UDI-DIDate24 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  • Withdrawn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
6 in 1 Multi-Parameter Monitoring System II
Model / Reference
M-601, M-601-0014
Primary DI / UDI-DI
06978467910986
Basic UDI-DI
697846791M-60100001X5
Direct Marketing DI
06978467910986
EMDN Code
W020106019099 Various diabetes monitoring instruments - other
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000048311
Authorised representative
Lotus NL B.V. NL-AR-000000121

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