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SHURUI Curved Bipolar Dissector
EUDAMEDClass IIb (EU MDR)
Ref SR-ENT-SP0801SRef SR-ENT-SP0801
Identity
- Trade Name
- SHURUI Curved Bipolar Dissector EUDAMED
- Device Name
- Endoscopic Surgical System, surgical instruments, 3D endoscope and accessories EUDAMED
- Model / Reference
- SR-ENT-SP0801S EUDAMEDSR-ENT-SP0801 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974191198126 EUDAMED06974191198119 EUDAMED
- Basic UDI-DI
- 697419119Endo-systemE5 EUDAMED
- Direct Marketing DI
- 06974191198126 EUDAMED06974191198119 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 Curved Bipolar Dissector by Beijing Surgerii Robotics Company Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical arm system.
- daVinci Xi — Intuitive Surgical, Inc. · Class II
- FLEX — Medrobotics Corporation · Class II
- Flex — Medrobotics Corporation · Class II
- Adapter, Bipolar Large Grasping Forceps, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
- FLEX — Medrobotics Corporation · Class II
- Senhance — Asensus Surgical, Inc. · Class II
- 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 9e4bf976-8250-44ab-8476-eb7e83c73d78 61 fields · synced Jul 29, 2026
- EUDAMED ace146f2-3d4a-41a0-9f85-cfebaace289e 61 fields · synced May 18, 2026