Identity
- Device Name
- Endoscope camera system EUDAMED
- Model / Reference
- SD-HD668P EUDAMEDSD-618 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971244214352 EUDAMED06971244214956 EUDAMED
- Basic UDI-DI
- 697124421CS000246 EUDAMED697124421CS00064E EUDAMED
- EMDN Code
- Z12020401 INTEGRATED SYSTEMS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Endoscope camera system by Shenyang Shenda Endoscope 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 | 697124421CS000246 | Class I | Active |
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Manufacturer
- Manufacturer
- Shenyang Shenda Endoscope Co., Ltd.
- EUDAMED SRN
- CN-MF-000030478
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (2)
- EUDAMED 1b0a9205-cd9e-4d9e-a6c0-d951c1df402a 61 fields · synced Aug 3, 2026
- EUDAMED d19fb513-7230-4293-b75c-e5f9761de71e 61 fields · synced May 19, 2026