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Medical Endoscopic Camera Systems And Cold Light Source
EUDAMEDClass I (EU MDR)
Ref E12AModel E42A,E12A,E20A,E20B,E22A,E22B,E40A,E40B,E42B,E33,E43,E33N,E43N,E10U,E9U,KS-ELS100A,KS-ELS200A, KS-ELS280A,KS-ELS300A,KS-ELS05
Identity
- Device Name
- Medical Endoscopic Camera Systems And Cold Light Source EUDAMED
- Model / Reference
- E42A,E12A,E20A,E20B,E22A,E22B,E40A,E40B,E42B,E33,E43,E33N,E43N,E10U,E9U,KS-ELS100A,KS-ELS200A, KS-ELS280A,KS-ELS300A,KS-ELS05 EUDAMEDE12A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974471531469 EUDAMED
- Basic UDI-DI
- 697447153146LZ EUDAMED
- EMDN Code
- Z12020401,Z12020402 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Medical Endoscopic Camera Systems And Cold Light Source by Shantou Easywell Electronic Technologies Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 697447153146LZ | Class I | Active |
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Manufacturer
- Manufacturer
- Shantou Easywell Electronic Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000016725
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 82881514-d348-4ced-ac2a-5bef8bebb58c 61 fields · synced Jun 18, 2026