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Surgical Light

by Shinva Medical Instrument Co., Ltd. 8 variants

Ref SMart-M35plusModel SMart-L40plus; SMart-L35plus; SMart-R40plus; SMart-L80plus/L70plusSMart-L80plusSMart-L70plusSMart-L40plus/L35plusSMart-M35plus; SMart-M35.

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697061496140002RN Basic UDI-DI 06970614968673UDI-DIDate13 Jan 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
SMart-L40plus, SMart-L35plus, SMart-R40plus, SMart-L80plus/L70plusSMart-L80plusSMart-L70plusSMart-L40plus/L35plusSMart-M35plus, SMart-M35., SMart-M35plus
Primary DI / UDI-DI
06970614968673
Basic UDI-DI
697061496140002RN
Direct Marketing DI
06970614968673
EMDN Code
Z12010701 Fixed scialytic lamps
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009856
Authorised representative
MedNet EC-REP C IIb GmbH DE-AR-000011194

Other devices from Shinva Medical Instrument Co., Ltd.

See all devices from Shinva Medical Instrument 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