Identity
- Trade Name
- Chirurgenkonsole EUDAMED
- Device Name
- Endoscopic instrument control system EUDAMED
- Model / Reference
- MP1000 EUDAMEDMP1101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942854300018 EUDAMED
- Basic UDI-DI
- 697507099EICS0LS EUDAMED
- Direct Marketing DI
- 06942854300018 EUDAMED
- EMDN Code
- Z12020101 ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Chirurgenkonsole by Shenzhen Edge Medical Co., Ltd. — Class IIb — 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 | 697507099EICS0LS | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shenzhen Edge Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000039045
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2b18df9c-05ce-40f0-8e12-e6285cbe68c8 61 fields · synced Jun 20, 2026