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SHURUI Sterile Drape

by Beijing Surgerii Robotics Company Limited 2 variants

Ref SR-ENS-600-D2Model SR-ENS-600-D1, SR-ENS-600-D2

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 16974191191865UDI-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  • Withdrawn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 Sterile Drape
SHURUI Sterile Drape SR-ENS-600-D2
Device Name
Endoscopic Surgical System, surgical instruments, 3D endoscope and accessories
Sterile drape
Model / Reference
SR-ENS-600-D2, SR-ENS-600-D1
Primary DI / UDI-DI
16974191191865
Basic UDI-DI
697419119Endo-systemE5, 697419119SD001GA
EMDN Code
Z12029085 Various instruments for endoscopy and mini-invasive surgery - consumables
Device Class
Class IIb
Class I
EU market of registration
Netherlands
Spain

Manufacturer details

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

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Properties

  • Sterile
  • Reusable YesEUDAMEDNoEUDAMED

Other properties (11)

  • 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