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SHURUI Sterile Drape
EUDAMEDClass IIb (EU MDR)
Ref SR-ENS-600-D1Ref SR-ENS-600-D2
Identity
- Trade Name
- SHURUI Sterile Drape EUDAMED
- Device Name
- Endoscopic Surgical System, surgical instruments, 3D endoscope and accessories EUDAMED
- Model / Reference
- SR-ENS-600-D1 EUDAMEDSR-ENS-600-D2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974191191858 EUDAMED16974191191865 EUDAMED
- Basic UDI-DI
- 697419119Endo-systemE5 EUDAMED
- EMDN Code
- Z12029085 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
SHURUI Sterile Drape by Beijing Surgerii Robotics Company Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 6b71a117-04eb-4d62-aac1-676b99e76340 61 fields · synced Jul 17, 2026
- EUDAMED 10a7af16-49f6-4289-b780-77bfcef7f5c3 61 fields · synced May 18, 2026