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Paxman Scalp Cooling System
EUDAMEDClass IIa (EU MDR)
Ref PSCS 2 230VRef PSCS 1 230V
Identity
- Trade Name
- Paxman Scalp Cooling System EUDAMED
- Device Name
- Paxman Scalp Cooling System EUDAMED
- Model / Reference
- PSCS 2 230V EUDAMEDPSCS 1 230V EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B561PSCS2230V0 EUDAMED+B561PSCS1230V0 EUDAMED
- Basic UDI-DI
- ++B561PSCS2230VZT EUDAMED++B561PSCS1230VZG EUDAMED
- Direct Marketing DI
- +B561PSCS2230V0 EUDAMED+B561PSCS1230V0 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Paxman Scalp Cooling System by Paxman Coolers Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B561PSCS2230VZT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Paxman Coolers Ltd
- EUDAMED SRN
- GB-MF-000011493
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED fc5d9dd6-f85c-43cf-b0ea-e787fac773de 61 fields · synced Jul 12, 2026
- EUDAMED b601cf69-8de8-430b-b939-db7b3f36c548 61 fields · synced May 17, 2026