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RADIA Adapter
EUDAMEDClass IIa (EU MDR)
Ref X9000009Model Senhance Motorized Adapters
Identity
- Trade Name
- RADIA Adapter EUDAMED
- Device Name
- Senhance Motorized Adapters EUDAMED
- Model / Reference
- Senhance Motorized Adapters EUDAMEDX9000009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815440021863 EUDAMED
- Basic UDI-DI
- 081544002TD004AQ9 EUDAMED
- Direct Marketing DI
- 00815440021863 EUDAMED
- EMDN Code
- Z1202018099 REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Category: Robotic surgical arm system
RADIA Adapter by Asensus Surgical Italia S.r.l. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical arm system.
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- Senhance — Asensus Surgical, Inc. · Class II
- ARTAS System — Venus Concept Inc. · Class II
- daVinci Si — Intuitive Surgical, Inc. · Class II
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 | 081544002TD004AQ9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Asensus Surgical Italia S.r.l.
- EUDAMED SRN
- IT-MF-000007964
Sources (1)
- EUDAMED 78aba7a9-741d-48ee-9fc1-c7bd4c964cac 61 fields · synced Jul 12, 2026