Identity
- Trade Name
- Endoscopic instrument control system EUDAMED
- Device Name
- Endoscopic instrument control system EUDAMED
- Model / Reference
- SP1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975070997243 EUDAMED
- Basic UDI-DI
- 697507099EICS1LU EUDAMED
- Direct Marketing DI
- 06975070997243 EUDAMED
- EMDN Code
- Z12020101 ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Endoscopic instrument control system 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 | 697507099EICS1LU | 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 9270746f-000c-4e63-bda0-5a1c141765db 61 fields · synced Aug 1, 2026