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Shadowless Surgical Lamp
EUDAMEDClass I (EU MDR)
Ref HyLED500Ref HyLED700Ref HyLED700/500
Identity
- Trade Name
- Shadowless Surgical Lamp EUDAMED
- Device Name
- Shadowless Surgical Lamp EUDAMED
- Model / Reference
- HyLED500 EUDAMEDHyLED700 EUDAMEDHyLED700/500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978356270030 EUDAMED06978356270023 EUDAMED06978356270016 EUDAMED
- Basic UDI-DI
- 697835627SSLZD EUDAMED
- Direct Marketing DI
- 06978356270030 EUDAMED06978356270023 EUDAMED06978356270016 EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Shadowless Surgical Lamp by SHANDONG HORO MEDICAL EQUIPMENT 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 | 697835627SSLZD | Class I | Active |
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Manufacturer
- Manufacturer
- SHANDONG HORO MEDICAL EQUIPMENT Co., Ltd.
- EUDAMED SRN
- CN-MF-000046718
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (3)
- EUDAMED 08c84fa9-0ec9-4e36-9cda-113655064663 61 fields · synced Oct 6, 2026
- EUDAMED 040354ea-ce3d-40fc-bbc5-c5f44084e5a5 61 fields · synced May 17, 2026
- EUDAMED 103980e6-17ee-4f3b-afd4-fa0d7dacb9f5 61 fields · synced May 18, 2026