Electrocardiograph
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. China EUDAMED
Ref BeneHeart R700Model BeneHeart R900\BeneHeart R90\BeneHeart R700\BeneHeart R70\BeneHeart R300\BeneHeart R30
EMDN Z12050301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69449040AB010000573T | Date18 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- BeneHeart R900\BeneHeart R90\BeneHeart R700\BeneHeart R70\BeneHeart R300\BeneHeart R30, BeneHeart R700
- Primary DI / UDI-DI
- 06903053074926
- Basic UDI-DI
- 69449040AB010000573T
- EMDN Code
- Z12050301 General purpose electrocardiographs
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000014156
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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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 05e61029-a748-43a3-963a-3eaa9ece469e