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Paxman Scalp Cooling System

by Paxman Coolers Ltd 2 variants

Ref PSCS 1 230V

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B561PSCS1230VZG Basic UDI-DI +B561PSCS1230V0UDI-DIDate15 Feb 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

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