Pacrac+ Suit Power X1
by Ferno Australia Pty Ltd EUDAMED
Active
Ref FWEPR+PX1
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number93484980FWEPR+ZE | Date18 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- PacRac+
- Model / Reference
- FWEPR+PX1
- Primary DI / UDI-DI
- 09348498001972
- Basic UDI-DI
- 93484980FWEPR+ZE
- Direct Marketing DI
- 09348498001972
- EMDN Code
- V0880 Medical support equipment - accessories
- Device Class
- Class I
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- AU-MF-000035726
- Authorised representative
- Ferno S.r.l. IT-AR-000031265
Other devices from Ferno Australia Pty Ltd
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