FloTrac
by Edwards Lifesciences LLC United States EUDAMED
Ref MHD6R
EMDN Z1203020301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0690103D001FAS000PZ | Date30 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Hemodynamic Monitoring Disposables (Sterile, Single Use, Active, Non-Implantable)
- Model / Reference
- MHD6R
- Primary DI / UDI-DI
- 00690103220094
- Basic UDI-DI
- 0690103D001FAS000PZ
- EMDN Code
- Z1203020301 Invasive blood pressure monitoring instruments
- Device Class
- Class IIa
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000007139
- Authorised representative
- Edwards Lifesciences GmbH DE-AR-000006184
Other devices from Edwards Lifesciences LLC
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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 00690103220094|0690103D001FAS000PZ