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Endoscopic Light Source
EUDAMEDClass I (EU MDR)
Ref HL2000-L1-NModel HL2000-L1 、HL2000-L1-N、HL5000-L1 、HL5000-L1-N
Identity
- Device Name
- Endoscopic Light Source EUDAMED
- Model / Reference
- HL2000-L1 、HL2000-L1-N、HL5000-L1 、HL5000-L1-N EUDAMEDHL2000-L1-N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975202770249 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
Endoscopic Light Source by Hunan Endoso Life Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 (1)
- EUDAMED 3c8bbc3b-a11f-43bf-b5a4-11588e4f7949 61 fields · synced Jun 18, 2026