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Manipulator Arm
EUDAMEDClass IIb (EU MDR)
Ref X9000005Model Senhance Surgical System
Identity
- Trade Name
- Manipulator Arm EUDAMED
- Device Name
- Senhance Surgical System Capital Equipment EUDAMED
- Model / Reference
- Senhance Surgical System EUDAMEDX9000005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00815440020293 EUDAMED
- Basic UDI-DI
- 081544002TD004UK EUDAMED
- EMDN Code
- Z12020101 ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb 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
Manipulator Arm by Asensus Surgical Italia S.r.l. — 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 | 081544002TD004UK | Class IIb | Active |
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Manufacturer
- Manufacturer
- Asensus Surgical Italia S.r.l.
- EUDAMED SRN
- IT-MF-000007964
Sources (1)
- EUDAMED d9433442-93f0-4b83-8762-f5f1afe7c294 61 fields · synced Jun 17, 2026