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Ultrasonic Generator
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref X9007621Model Senhance Ultrasonic Surgical System
Identity
- Trade Name
- Ultrasonic Generator EUDAMEDSenhance Ultrasonic FDA UDI
- Generic Name
- Electrosurgical/ultrasonic surgical system generator FDA UDI
- Device Name
- Ultrasonic Generator EUDAMEDSenhance Ultrasonic Generator FDA UDI
- Model / Reference
- Senhance Ultrasonic Surgical System EUDAMEDX9007621 EUDAMEDFDA UDI
- Description
- Senhance Ultrasonic Generator FDA UDI
Identifiers
- Catalog Number
- 300-01010 FDA UDI
- Primary DI / UDI-DI
- 00815440021580 EUDAMEDFDA UDI
- Basic UDI-DI
- 081544002TD003UH EUDAMED
- Direct Marketing DI
- 00815440021580 EUDAMED
- 510(k) Number
- K182421 FDA UDI
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- L1306 ULTRASONIC GENERATOR ROBOTIC SURGERY INSTRUMENTS, REUSABLE EUDAMED
- GMDN Term
- Electrosurgical/ultrasonic surgical system generator 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
Yes
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
Ultrasonic Generator 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 | 081544002TD003UH | 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 abecce62-398c-42ff-bca9-a45b09d807b3 61 fields · synced Jul 28, 2026
- FDA UDI 9b1d9364-1024-48e9-9a07-9eedac8ec4c6 35 fields · synced May 30, 2026