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Hand Light Source Set
EUDAMEDClass I (EU MDR)
Ref NoneModel LEDRef P9421Ref P2317EModel LED-200,LED-100,LED-800
Identity
- Trade Name
- Hand Light Source Set EUDAMED
- Device Name
- Hand Light Source Set EUDAMEDLight Source EUDAMED
- Model / Reference
- LED EUDAMEDNone EUDAMEDP9421 EUDAMEDLED-200,LED-100,LED-800 EUDAMEDP2317E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947014610181 EUDAMED06947014611683 EUDAMED06947014621071 EUDAMED
- Basic UDI-DI
- 69470146DQ00082410K7 EUDAMED69470146DQ00485110LZ EUDAMED
- Direct Marketing DI
- 06947014611683 EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMEDZ12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDItaly EUDAMEDBelgium 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
Hand Light Source Set by Hangzhou Hawk Optical Electronic Instruments 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 | 69470146DQ00082410K7 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000028791
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED 8cdfe2dd-a50b-41bb-a94a-d12dadd6f9d9 61 fields · synced Sep 18, 2026
- EUDAMED 5d0e06bf-47aa-4c6c-b590-468d74f1537a 61 fields · synced May 17, 2026
- EUDAMED 38f0487c-bf74-44b5-9b64-71bb0ab73c37 61 fields · synced Jul 21, 2026