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Neonatal Incubator

by Shenzhen Comen Medical Instruments Co., LTD. China EUDAMED

Ref B3Model B8

EMDN Z1208040302

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number69454290NI001MQ Basic UDI-DIDate3 Apr 2026RegisteredStatusActive
European UnionCE/MDR Number69454290NI001MQ Basic UDI-DIDate3 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
B8, B3
Primary DI / UDI-DI
06945429090031
Basic UDI-DI
69454290NI001MQ, 69454290NI003MU
Direct Marketing DI
06945429090031
EMDN Code
Z1208040302 Mobile neonatal incubators
Device Class
Class IIb
Market of Registration
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 & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • Sterile: No
  • Implantable: No
  • Reusable: 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

Sources (2)

  • EUDAMED 7690d4fe-eb8f-412f-aa6e-5578b8895855 61 fields · synced 24 Oct 2026
  • EUDAMED 06945429090031|69454290NI003MU 61 fields · synced 24 Oct 2026