Skip to content

BIPA freeze spray

by Volcke Aerosol Italy S.r.l.

Ref 9484

Active European Union

CE MDR

Valid until

27 Nov 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Eurofins Product Testing Italy S.r.l.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number801140000ICE6A Basic UDI-DI 08011400016890UDI-DIDate19 Feb 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.25/6000 Active

    Quality management system EU MDR

    Certifier
    Eurofins Product Testing Italy S.r.l. 0477
    Issued
    28 Nov 2025
    Expires
    27 Nov 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Ghiaccio Spray, Ice Spray
Model / Reference
9484
Primary DI / UDI-DI
08011400016890
Basic UDI-DI
801140000ICE6A
EMDN Code
M9001 Cryotherapy and thermotherapy devices
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IT-MF-000029086

Other devices from Volcke Aerosol Italy S.r.l.

  • Freeze Spray

    Class IIa

Properties

  • Incorporates Medicinal Product

Other properties (12)

  • 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