Medisono
by Medisono LCC EUDAMEDGUDID
Active
Ref MUS05190Model P3
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++B369MUS0EN | Date4 Feb 2022 | StatusActive |
| United States | GUDID listing GUDID | NumberB369MUS05190 | Date17 Dec 2021 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Generic Name
- General-purpose ultrasound imaging system
- Device Name
- Digital Ultrasonic Diagnostic Imaging System
- Model / Reference
- P3 EUDAMEDMUS05190 EUDAMEDLINEAR ARRAY PROBE MODEL L741FOR P10 PLUS GUDID
- Primary DI / UDI-DI
- B369MUS05190
- 510(k) Number
- FDA Product Code
- IYN
- GMDN Term
- General-purpose ultrasound imaging system
- Regulation Number
- 892.1550
- Market of Registration
- Italy
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | P3 MUS05190 | LINEAR ARRAY PROBE MODEL L741FOR P10 PLUS |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000004807
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293