M’AthPACS
by Imt France EUDAMEDGUDID
Ref M’AthPACS V3.2.X Product code LLZEMDN Z11049082
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number376026469MATHPACS3XY6X | Date21 Feb 2022 | StatusActive |
| United States | GUDID listing GUDID | Number03760264690115 | Date24 Sep 2019 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- M'Ath PACS
- Generic Name
- Cardiovascular risk evaluation interpretive software
- Device Name
- M’AthPACS
- Model / Reference
- M’AthPACS V3.2.X EUDAMED3.2.1 GUDID
- Primary DI / UDI-DI
- 03760264690115
- Basic UDI-DI
- 376026469MATHPACS3XY6X
- Direct Marketing DI
- 03760264690115
- 510(k) Number
- FDA Product Code
- LLZ
- EMDN Code
- Z11049082 Various ultrasound instruments - software accessories
- GMDN Term
- Cardiovascular risk evaluation interpretive software
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.2050
- Special Device Type
- Software
- Market of Registration
- France
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | M’AthPACS V3.2.X | 3.2.1 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- FR-MF-000004673
Other devices from Imt
Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
Sources (2)
- EUDAMED a9804da0-ae07-43ef-9bf9-adef3ff968f4
- FDA UDI c2f839bc-a63e-44be-b919-39b62322c7a0