Identity
- Trade Name
- Sentire Surgical System EUDAMED
- Device Name
- 8 mm Cannula, 10 mm Cannula EUDAMED
- Model / Reference
- ACNL1, ACNL2 EUDAMEDACNL1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974771910827 EUDAMED
- Basic UDI-DI
- 697477191BS0013GX EUDAMED
- Direct Marketing DI
- 06974771910827 EUDAMED
- EMDN Code
- L1307 ROBOTIC SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Sentire Surgical System by Cornerstone Technology (Shenzhen) Limited — Class IIa — 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 | 697477191BS0013GX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cornerstone Technology (Shenzhen) Limited
- EUDAMED SRN
- CN-MF-000046027
- Authorised Representative
- Cornerstone Robotics B.V. NL-AR-000045469
Sources (1)
- EUDAMED e934d687-939e-4053-aecc-924bd3775bba 61 fields · synced Jul 31, 2026