Identity
- Device Name
- LED Shadowless Operating Lamps EUDAMED
- Model / Reference
- / EUDAMEDEZ5000/7000D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979909985708 EUDAMED
- Basic UDI-DI
- 697990998SOL00174 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
LED Shadowless Operating Lamps by Fepdon (Nanjing) Medical Technology 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 | 697990998SOL00174 | Class I | Active |
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Manufacturer
- Manufacturer
- Fepdon (Nanjing) Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000057056
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED 561181cd-f956-4e5d-a09e-b5432c2257fb 61 fields · synced Aug 1, 2026