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Surgical Light

by Hunan Mplent Optoelectronics Technology Co., Ltd

Model ZW-700/500E ZW-700/700E ZW-700E ZW-500E ZW-500E(L) ZW-700/500D ZW-700/700D ZW-700D ZW-500D ZW-500D(L) ZW-K700/500H ZW-K700/500 ZW-K700/700H ZW-K700/700 ZW-K500/500H ZW-K500 etc

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 Number697618018ZW001P3 Basic UDI-DI 06976180181010UDI-DIDate13 Apr 2023RegisteredStatusActive

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  • Withdrawn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
Surgical Light
Model / Reference
ZW-700/500E ZW-700/700E ZW-700E ZW-500E ZW-500E(L) ZW-700/500D ZW-700/700D ZW-700D ZW-500D ZW-500D(L) ZW-K700/500H ZW-K700/500 ZW-K700/700H ZW-K700/700 ZW-K500/500H ZW-K500 etc
Primary DI / UDI-DI
06976180181010
Basic UDI-DI
697618018ZW001P3
EMDN Code
Z12010701, Z12010702, Z12010780, Z12010785, Z12010799
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000034224
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Hunan Mplent Optoelectronics Technology Co., Ltd

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