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Endoscopic Light Source
EUDAMEDClass I (EU MDR)
Ref HL2000-L1Model HL2000-L1 、HL2000-L1-N、HL5000-L1 、HL5000-L1-NRef HL5000-L1Ref HL5000-L1-N
Identity
- Device Name
- Endoscopic Light Source EUDAMED
- Model / Reference
- HL2000-L1 、HL2000-L1-N、HL5000-L1 、HL5000-L1-N EUDAMEDHL2000-L1 EUDAMEDHL5000-L1 EUDAMEDHL5000-L1-N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202770232 EUDAMED06975202770584 EUDAMED06975202770591 EUDAMED
- Basic UDI-DI
- 697520277002HZ EUDAMED
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Endoscopic light source unit, line-powered
Endoscopic Light Source by Hunan Endoso Life Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Endoscopic light source unit, line-powered.
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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 | 697520277002HZ | Class I | Active |
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Manufacturer
- Manufacturer
- Hunan Endoso Life Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000021400
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED 347a3a93-54ab-4851-ba4c-f247cd29da2b 61 fields · synced Jul 21, 2026
- EUDAMED a9395fa2-b882-4782-8804-0e26b20c7687 61 fields · synced May 18, 2026
- EUDAMED e3fe3b6f-0814-46c5-abc1-e624a30278a4 61 fields · synced May 19, 2026