Edra Pro
by Resilience MD France EUDAMED
Ref EDRA PRO Model EDRA PRO V1
EMDN Z12040192
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number39467 | Date26 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 39467 Amended
Quality management system EU MDR
- Notified body
- GMED SAS 0459
- Issued
- 26 May 2026
- Expires
- 16 Nov 2028
- Reason
- Mnf data change
Specification
- Model / Reference
- EDRA PRO V1, EDRA PRO
- Primary DI / UDI-DI
- 03760356940050
- Basic UDI-DI
- 376035694EdraproR3
- Direct Marketing DI
- 03760356940050
- EMDN Code
- Z12040192 General medicine diagnosis and monitoring instruments - medical device software
- Device Class
- Class IIa
- Special Device Type
- Software
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000000678
Other devices from Resilience MD
Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 0daf48be-56b2-4dc4-9ca8-a75689596847