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Shadowless Operating Lamp
EUDAMEDClass I (EU MDR)
Ref /Model 700/500LED、500/500LED、700/700LED、SY02-LED3+5、SY02-LED3+3、 HF-L3+4CLED HF-L4+4CLED HF-L3+3CLED.etc
Identity
- Device Name
- Shadowless Operating Lamp EUDAMED
- Model / Reference
- 700/500LED、500/500LED、700/700LED、SY02-LED3+5、SY02-LED3+3、 HF-L3+4CLED HF-L4+4CLED HF-L3+3CLED.etc EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945798654124 EUDAMED
- Basic UDI-DI
- 69457986HFSOL001KS EUDAMED
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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 Operating Lamp by Shanghai Huifeng 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 | 69457986HFSOL001KS | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Huifeng Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000022480
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a2ffe3c9-6687-4279-9ac7-ab2a5ef2f4ba 61 fields · synced Jun 19, 2026