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Manipulator Arm, ISU Configuration
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref X9007708Model Senhance Surgical System
Identity
- Trade Name
- Manipulator Arm, ISU Configuration EUDAMEDSenhance FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- Senhance Surgical System Capital Equipment EUDAMEDSenhance Manipulator Arm, ISU Configuration FDA UDI
- Model / Reference
- Senhance Surgical System EUDAMEDX9007708 EUDAMEDFDA UDI
- Description
- Senhance Manipulator Arm, ISU Configuration FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815440022075 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
Manipulator Arm, 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 |
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Manufacturer
- Manufacturer
- Asensus Surgical Italia S.r.l.
- EUDAMED SRN
- IT-MF-000007964
Sources (2)
- EUDAMED 899af3bd-1a6c-4d55-8642-c001a3cf9e60 61 fields · synced Jun 18, 2026
- FDA UDI 38f7f7e1-ded5-4f00-9fae-208d1833304f 33 fields · synced May 29, 2026