Identity
- Trade Name
- Sentire Surgical System EUDAMED
- Device Name
- 5-8 mm Cannula Seal, 8-10 mm Cannula Seal EUDAMED
- Model / Reference
- ACNS1, ACNS2 EUDAMEDACNS2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 86974771911035 EUDAMED
- Basic UDI-DI
- 697477191BS0014GZ EUDAMED
- EMDN Code
- K01010106 ROBOTIC SURGERY TROCAR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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 I — 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 | 697477191BS0014GZ | Class I | 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 96da3241-ca8d-46f9-b243-f5a54f0582ed 61 fields · synced Jul 31, 2026