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Specialized Neonatal Monitor

by Shenzhen Comen Medical Instruments Co., LTD. 5 variants

Ref Datalys 760, K90, K90A, K60A, K80Model K60

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDR NumberB-06945429020878 Basic UDI-DI Date24 Apr 2022RegisteredStatusActive
European UnionCE/MDD NumberB-06945429020878 Basic UDI-DI Date24 Apr 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / Reference
Datalys 760, K60, K90, K90A, K60A, K80
Primary DI / UDI-DI
06945429020878, 06945429027938, 06945429027945, 06945429027907, 06945429027891, 06945429027914
Basic UDI-DI
B-06945429020878, 69454290SN001QJ
Direct Marketing DI
06945429027938
06945429027945
06945429027907
06945429027891
06945429027914
EMDN Code
Z1203020201 Multi–parameter patient bedside monitors
Device Class
Class IIb
EU market of registration
Belgium
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000002236
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Comen Medical Instruments Co., LTD.

See all devices from Shenzhen Comen Medical Instruments Co., LTD. →

Properties

  • Reusable NoEUDAMEDYesEUDAMED
  • Measuring Function

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No