Paxman Scalp Cooling System
by Paxman Coolers Ltd 2 variants
Ref PSCS 1 230V
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++B561PSCS1230VZG +B561PSCS1230V0 | Date15 Feb 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- PSCS 1 230V
- Primary DI / UDI-DI
- +B561PSCS1230V0
- Basic UDI-DI
- ++B561PSCS1230VZG
- Direct Marketing DI
- +B561PSCS1230V0
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class IIa
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- GB-MF-000011493
- Authorised representative
- MedEnvoy Global BV NL-AR-000024028
Other devices from Paxman Coolers 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