Identity
- Trade Name
- SHURUI Endoscopic Surgical System EUDAMED
- Device Name
- Endoscopic Surgical System, surgical instruments, 3D endoscope and accessories EUDAMED
- Model / Reference
- SR-ENS-600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974191198003 EUDAMED
- Basic UDI-DI
- 697419119Endo-systemE5 EUDAMED
- EMDN Code
- Z12020101 ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb 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
SHURUI Endoscopic Surgical System by Beijing Surgerii Robotics Company Limited — 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 | 697419119Endo-systemE5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing Surgerii Robotics Company Limited
- EUDAMED SRN
- CN-MF-000038927
- Authorised Representative
- Surgerii Robotics (Netherlands) B.V. NL-AR-000049854
Sources (1)
- EUDAMED 8b4cc30e-76ad-434e-b6b2-83fd0294f391 61 fields · synced Jul 17, 2026