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Helmets for Non Invasive Ventilation

by Intersurgical SpA 91 variants

Ref CA012M/2W

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number80583230DCCASCHIKD Basic UDI-DI 08058323000360UDI-DIDate5 May 2022RegisteredStatusActive

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  • Withdrawn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

Device Name
Helmets for Non Invasive Ventilation
Model / Reference
CA012M/2W
Primary DI / UDI-DI
08058323000360
Basic UDI-DI
80583230DCCASCHIKD
Direct Marketing DI
08058323000360
EMDN Code
R0301010401 Cpap helmets and kits
Device Class
Class IIa
EU market of registration
Lithuania

Manufacturer details

EUDAMED SRN
IT-MF-000010729

Other devices from Intersurgical SpA

See all devices from Intersurgical SpA →

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