Identity
- Trade Name
- Sentire Surgical System EUDAMED
- Device Name
- 8 mm Permanent Cautery Hook, 8 mm Permanent Cautery Spatula EUDAMED
- Model / Reference
- TPCH4, TPCS4 EUDAMEDTPCH4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974771910681 EUDAMED
- Basic UDI-DI
- 697477191BS0003GU EUDAMED
- Direct Marketing DI
- 06974771910681 EUDAMED
- EMDN Code
- L180102 ENDOSCOPIC ELECTROSURGERY DISSECTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIb 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 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 | 697477191BS0003GU | Class IIb | 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 402a15c4-c062-4e96-9908-84ccb45fb0d2 61 fields · synced Jul 26, 2026