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SunLED 11B
EUDAMEDClass I (EU MDR)
Ref SunLED 11BModel SunLED 1
by Mediland Medical Equipment Enterprise Corporation Company
Identity
- Trade Name
- SunLED 11B EUDAMED
- Device Name
- SunLED Series Surgical Light EUDAMED
- Model / Reference
- SunLED 1 EUDAMEDSunLED 11B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974724356115 EUDAMED
- Basic UDI-DI
- 697472435SunLEDHC EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
SunLED 11B by Mediland Medical Equipment Enterprise Corporation Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697472435SunLEDHC | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000014619
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (1)
- EUDAMED ff82b040-a43b-47d7-979c-8ccfef2078ad 61 fields · synced Oct 6, 2026