Melody Patient
by Advanced Echo Technology France EUDAMEDGUDID
Ref MEL; PCI; PRW Product code IYOEMDN Z11049080
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number3770015437MELODYPGD | Date11 Mar 2022 | StatusActive |
| United States | GUDID listing GUDID | Number03770015437012 | Date24 Jan 2022 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Melody
- Generic Name
- Video consultation telemedicine system
- Device Name
- Melody Patient
- Model / Reference
- MEL EUDAMEDPCI EUDAMEDPRW EUDAMEDMELODY PATIENT GUDID
- Primary DI / UDI-DI
- 03770015437012
- Basic UDI-DI
- 3770015437MELODYPGD
- 510(k) Number
- FDA Product Code
- IYO, ITX, IYN
- EMDN Code
- Z11049080 Various ultrasound instruments - hardware accessories
- GMDN Term
- Video consultation telemedicine system
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.1560, 892.1570, 892.1550
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | MEL; PCI; PRW | MELODY PATIENT |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- FR-MF-000000599
Other devices from Advanced Echo Technology
Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 2f5467ce-389e-4563-9848-f07e8ab5f350
- FDA UDI 698f1456-ee70-4a41-b40b-5772ec3d24d5