Identity
- Trade Name
- Sentire Surgical System EUDAMED
- Device Name
- 8 mm Large Needle Driver, 8 mm ExtraLarge Needle Driver EUDAMED
- Model / Reference
- TLND4, TXND4 EUDAMEDTLND4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974771910698 EUDAMED
- Basic UDI-DI
- 697477191BS0004GW EUDAMED
- Direct Marketing DI
- 06974771910698 EUDAMED
- EMDN Code
- L1399 ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER 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
Category: Robotic surgical forceps, reusable
Sentire Surgical System by Cornerstone Technology (Shenzhen) Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Robotic surgical forceps, reusable.
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- Right Angle Dissector, Long Ø 10 mm x length 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
- EndoWrist — Intuitive Surgical, Inc. · Class II
- Single-Site — Intuitive Surgical, Inc. · Class II
- Monopolar L-Hook Electrode Ø 5 mm x 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
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 | 697477191BS0004GW | 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 f7f14c3d-baae-48fc-8a7f-70311ce30b00 61 fields · synced Jul 16, 2026