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Manual Hospital Bed

by Hengshui Zhukang Medical Instrument Co., Ltd

Ref ZK01Model ZK01, ZK02, ZK03, ZK04, ZK05, ZK06, ZK07, ZK08, ZK09, ZK10, ZK10-1, ZK11, ZK11-1, ZK12, ZK12-1, ZK13, ZK13-1, ZK14, ZK14-1, ZK15, ZK15-1, ZK16, ZK16-1, ZK17, ZK17-1, ZK18,

Active European Union

CE MDR

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/MDR Number697771396HSZKYL002MN Basic UDI-DI 06977713960331UDI-DIDate2 Aug 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Manual Hospital Bed
Model / Reference
ZK01, ZK02, ZK03, ZK04, ZK05, ZK06, ZK07, ZK08, ZK09, ZK10, ZK10-1, ZK11, ZK11-1, ZK12, ZK12-1, ZK13, ZK13-1, ZK14, ZK14-1, ZK15, ZK15-1, ZK16, ZK16-1, ZK17, ZK17-1, ZK18
Primary DI / UDI-DI
06977713960331
Basic UDI-DI
697771396HSZKYL002MN
EMDN Code
V080602 Manual medical beds
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000042908
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No