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Surgical Light

by Shinva Medical Instrument Co., Ltd. China EUDAMED

Ref SMart-L35plusModel SMart-L40plus; SMart-L35plus; SMart-R40plus; SMart-L80plus/L70plusSMart-L80plusSMart-L70plusSMart-L40plus/L35plusSMart-M35plus; SMart-M35. EMDN Z12010701

Regulatory status

as of 25 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
SMart-L40plus, SMart-L35plus, SMart-R40plus, SMart-L80plus/L70plusSMart-L80plusSMart-L70plusSMart-L40plus/L35plusSMart-M35plus, SMart-M35.
Primary DI / UDI-DI
06970614968185
Basic UDI-DI
697061496140002RN
Direct Marketing DI
06970614968185
EMDN Code
Z12010701 Fixed scialytic lamps
Device Class
Class I
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 & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 06970614968185|697061496140002RN 61 fields · synced 25 Oct 2026