Identity
- Trade Name
- SHURUI Top Cover Incision Protector EUDAMED
- Device Name
- Endoscopic Surgical System, surgical instruments, 3D endoscope and accessories EUDAMED
- Model / Reference
- SR-TCIP-A-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974191191902 EUDAMED
- Basic UDI-DI
- 697419119Endo-systemE5 EUDAMED
- EMDN Code
- Z12029085 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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 Top Cover Incision Protector 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 8a8f3609-5c94-49ba-b686-590b7f024854 61 fields · synced Jul 15, 2026