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SHURUI Large Needle Driver
EUDAMEDClass IIb (EU MDR)
Ref SR-ENT-SP0810SRef SR-ENT-SP0810
Identity
- Trade Name
- SHURUI Large Needle Driver EUDAMED
- Device Name
- Endoscopic Surgical System, surgical instruments, 3D endoscope and accessories EUDAMED
- Model / Reference
- SR-ENT-SP0810S EUDAMEDSR-ENT-SP0810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974191198393 EUDAMED06974191198386 EUDAMED
- Basic UDI-DI
- 697419119Endo-systemE5 EUDAMED
- Direct Marketing DI
- 06974191198393 EUDAMED06974191198386 EUDAMED
- EMDN Code
- Z1202018099 REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES - OTHER 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
Category: Robotic surgical arm system
SHURUI Large Needle Driver by Beijing Surgerii Robotics Company Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Robotic surgical arm system.
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- ARTAS System — Venus Concept Inc. · Class II
- daVinci Si — Intuitive Surgical, Inc. · Class II
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 (2)
- EUDAMED dbaf9f1e-a7e3-42ff-aa01-3fe4f906b343 61 fields · synced Aug 3, 2026
- EUDAMED d0be6b17-f2f6-4a06-87f9-3bb7b8b5c390 61 fields · synced May 18, 2026