← Back to catalogue
SHURUI Needle Driver
EUDAMEDClass IIb (EU MDR)
Ref SR-ENT-SP0807SRef SR-ENT-SP0807
Identity
- Trade Name
- SHURUI Needle Driver EUDAMED
- Device Name
- Endoscopic Surgical System, surgical instruments, 3D endoscope and accessories EUDAMED
- Model / Reference
- SR-ENT-SP0807S EUDAMEDSR-ENT-SP0807 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974191198232 EUDAMED06974191198225 EUDAMED
- Basic UDI-DI
- 697419119Endo-systemE5 EUDAMED
- Direct Marketing DI
- 06974191198232 EUDAMED06974191198225 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 Needle Driver 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 |
Is this your device? Claim it to add documentation and request validation.
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 57d07b9a-91f6-4daf-a8b8-a16771f8dfcf 61 fields · synced Jul 20, 2026
- EUDAMED 60a7de3b-b62a-4749-8959-e715d035ee49 61 fields · synced May 18, 2026