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Sentire Surgical System
EUDAMEDClass IIa (EU MDR)
Ref AOBT4Model AOBT1, AOBT2, AOBT3, AOBT4
Identity
- Trade Name
- Sentire Surgical System EUDAMED
- Device Name
- 8 mm Obturator Dilating Tip, 8 mm Obturator Blunt Tip, 10 mm Obturator Dilating Tip, 10 mm Obturator Blunt Tip EUDAMED
- Model / Reference
- AOBT1, AOBT2, AOBT3, AOBT4 EUDAMEDAOBT4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 86974771910991 EUDAMED
- Basic UDI-DI
- 697477191BS0015H3 EUDAMED
- EMDN Code
- K01010106 ROBOTIC SURGERY TROCAR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa 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 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 | 697477191BS0015H3 | 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 d098f77e-147c-41f4-bfb7-6269fd156bec 61 fields · synced Sep 18, 2026