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Surgical Light
EUDAMEDClass I (EU MDR)
Ref SMart-L40plusModel SMart-L40plus; SMart-L35plus; SMart-R40plus; SMart-L80plus/L70plusSMart-L80plusSMartL70plusSMart-L40plus/L35plusSMart-M35plus; SMart-M35.
Identity
- Trade Name
- Surgical Light EUDAMED
- Device Name
- Surgical Light EUDAMED
- Model / Reference
- SMart-L40plus; SMart-L35plus; SMart-R40plus; SMart-L80plus/L70plusSMart-L80plusSMartL70plusSMart-L40plus/L35plusSMart-M35plus; SMart-M35. EUDAMEDSMart-L40plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970614968178 EUDAMED
- Basic UDI-DI
- 697061496140002RN EUDAMED
- Direct Marketing DI
- 06970614968178 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Operating room light system
Surgical Light by Shinva Medical Instrument Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697061496140002RN | Class I | Active |
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Manufacturer
- Manufacturer
- Shinva Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009856
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (1)
- EUDAMED a3f9c1a5-a1ef-473b-877b-e41e20f75b4c 61 fields · synced Jun 18, 2026