Padsy ECG 4.7
by Medset Medizintechnik GmbH Germany EUDAMED
Ref AAG138104 EMDN Z12050392
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number42504037AAG138000-00D4 | Date13 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 44911221064 Issued
Quality management system EU MDR
- Notified body
- Notified body 0044
- Issued
- 5 Jul 2024
- Expires
- 4 Jul 2029
Specification
- Device Name
- Padsy ECG
- Model / Reference
- AAG138104
- Primary DI / UDI-DI
- 04250403735245
- Basic UDI-DI
- 42504037AAG138000-00D4
- Direct Marketing DI
- 04250403735245
- EMDN Code
- Z12050392 Electrocardiographs - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- DE-MF-000016442
Other devices from Medset Medizintechnik GmbH
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 04250403735245|42504037AAG138000-00D4