Skip to content

SHURUI Needle Driver

by Beijing Surgerii Robotics Company Limited 2 variants

Ref SR-ENT-SP0807Model SR-ENT-SP0807, SR-ENT-SP0807S

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697419119Endo-systemE5 Basic UDI-DI 06974191198225UDI-DIDate19 Sep 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
SHURUI Needle Driver
SHURUI Needle Driver SR-ENT-SP0807
Device Name
Endoscopic Surgical System, surgical instruments, 3D endoscope and accessories
Needle driver
Model / Reference
SR-ENT-SP0807, SR-ENT-SP0807S
Primary DI / UDI-DI
06974191198225
Basic UDI-DI
697419119Endo-systemE5, 697419119SP0807KQ
Direct Marketing DI
06974191198225
EMDN Code
Z1202018099 Remote control robot-assisted endoscopic surgery instruments - hardware accessories - other
Device Class
Class IIb
Class IIa
EU market of registration
Netherlands
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000038927
Authorised representative
Surgerii Robotics (Netherlands) B.V. NL-AR-000049854

Related devices

Category: Robotic surgical arm system

Other devices from Beijing Surgerii Robotics Company Limited

See all devices from Beijing Surgerii Robotics Company Limited →

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No