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Infant Radiant Warmer

by Ningbo David Medical Device Co., Ltd. 19 variants

Ref HKN-93CModel HKN-500AB/HKN-500A/HKN-500B/HKN-500/HKN-93C/HKN-93CS

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number69207163HKN-003DD Basic UDI-DI Date24 May 2024RegisteredStatusActive
European UnionCE/MDR Number69207163HKN-003DD Basic UDI-DI Date24 May 2024RegisteredStatusActive

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  • Withdrawn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/MDD, CE/MDR Active

Specification

EUDAMED

Model / Reference
HKN-500AB/HKN-500A/HKN-500B/HKN-500/HKN-93C/HKN-93CS, HKN-93C
Primary DI / UDI-DI
06920716305258, 06920716303674
Basic UDI-DI
69207163HKN-003DD, B-06920716303674
Direct Marketing DI
06920716305258
EMDN Code
Z12080407 Neonatal radiant warmers
Device Class
Class IIb
EU market of registration
Germany
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000009962
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ningbo David Medical Device Co., Ltd.

See all devices from Ningbo David Medical Device Co., Ltd. →

Properties

  • 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