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SunLED 1
EUDAMEDClass I (EU MDR)
Ref SunLED 1Ref SunLED 1/MModel SunLED 1/MB、 SunLED 1/M
by Mediland Medical Equipment Enterprise Corporation Company
Identity
- Trade Name
- SunLED 1 EUDAMEDSunLED 1/M EUDAMED
- Device Name
- SunLED Series Surgical Light EUDAMEDSunLED Series Mobile Surgical Light EUDAMED
- Model / Reference
- SunLED 1 EUDAMEDSunLED 1/MB、 SunLED 1/M EUDAMEDSunLED 1/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974724356016 EUDAMED06974724357082 EUDAMED
- Basic UDI-DI
- 697472435SunLEDHC EUDAMED697472435SunLEDMobileNK EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMEDZ12010702 MOBILE 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
Category: Operating room light system
SunLED 1 by Mediland Medical Equipment Enterprise Corporation Company — 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 | 697472435SunLEDHC | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000014619
- Authorised Representative
- Luana Med. B.V. NL-AR-000002750
Sources (2)
- EUDAMED 65a4a578-ce0a-4539-9477-363e50f1a922 61 fields · synced Jul 17, 2026
- EUDAMED ee526310-4056-4149-b861-afeb249fe230 61 fields · synced May 18, 2026