HeartSave Y6 Display 7" and Accs.
by Metrax GmbH EUDAMED
Active
Ref 98267
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberG70 023787 0036 | Date17 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
EU market availability
Available in 32 countries, as listed in EUDAMED:
- Austria since 17 Mar 2025
- Belgium since 17 Mar 2025
- Bulgaria since 17 Mar 2025
- Croatia since 17 Mar 2025
- Cyprus since 17 Mar 2025
- Czechia since 17 Mar 2025
- Denmark since 17 Mar 2025
- Estonia since 17 Mar 2025
- Finland since 17 Mar 2025
- France since 17 Mar 2025
- Germany since 17 Mar 2025
- Greece since 17 Mar 2025
- Hungary since 17 Mar 2025
- Iceland since 17 Mar 2025
- Ireland since 17 Mar 2025
- Italy since 17 Mar 2025
- Latvia since 17 Mar 2025
- Liechtenstein since 17 Mar 2025
- Lithuania since 17 Mar 2025
- Luxembourg since 17 Mar 2025
- Malta since 17 Mar 2025
- Netherlands since 17 Mar 2025
- Northern Ireland since 17 Mar 2025
- Norway since 17 Mar 2025
- Poland since 17 Mar 2025
- Portugal since 17 Mar 2025
- Romania since 17 Mar 2025
- Slovakia since 17 Mar 2025
- Slovenia since 17 Mar 2025
- Spain since 17 Mar 2025
- Sweden since 17 Mar 2025
- Türkiye since 17 Mar 2025
Certificates
- G70 023787 0036 Issued
Technical documentation EU MDR
- Notified body
- TÜV SÜD Product Service GmbH 0123
- Issued
- 17 Mar 2025
- Expires
- 16 Mar 2030
Specification
- Device Name
- HeartSave Y
- Model / Reference
- 98267
- Primary DI / UDI-DI
- 04260648814841
- Basic UDI-DI
- 426064881HSYKJ
- EMDN Code
- Z12030501 Semi-automatic defibrillators
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005478
Other devices from Metrax GmbH
Properties
Show properties
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