← Back to catalogue
Cockpit, ISU Configuration
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref X9007707Model Senhance Surgical System
Identity
- Trade Name
- Cockpit, ISU Configuration EUDAMEDSenhance FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Senhance Surgical System Capital Equipment EUDAMEDSenhance Cockpit, ISU Configuration FDA UDI
- Model / Reference
- Senhance Surgical System EUDAMEDX9007707 EUDAMEDFDA UDI
- Description
- Senhance Cockpit, ISU Configuration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815440022082 EUDAMEDFDA UDI
- Basic UDI-DI
- 081544002TD004UK EUDAMED
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- Z12020101 ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS EUDAMED
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cockpit, ISU Configuration by Asensus Surgical Italia S.r.l. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081544002TD004UK | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Asensus Surgical Italia S.r.l.
- EUDAMED SRN
- IT-MF-000007964
Sources (2)
- EUDAMED 183713cc-f572-40e6-90ac-fcb6c2e4f8cc 61 fields · synced Jul 21, 2026
- FDA UDI 75b3a959-3a3d-445f-b821-ea0e100d6b95 33 fields · synced May 30, 2026