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F&P Orbit

by Fisher & Paykel Healthcare Limited 5 variants

Ref MR385

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 Number94200124CH01CR Basic UDI-DI 09420012480224UDI-DIDate27 Jul 2026RegisteredStatusActive

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  • Withdrawn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
Humidification Chamber
Model / Reference
MR385
Primary DI / UDI-DI
09420012480224
Basic UDI-DI
94200124CH01CR
Direct Marketing DI
09420012480316
EMDN Code
R060280 Humidification systems - accessories
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
NZ-MF-000002556
Authorised representative
FISHER & PAYKEL HEALTHCARE SAS FR-AR-000000294

Other devices from Fisher & Paykel Healthcare, Ltd.

See all devices from Fisher & Paykel Healthcare, 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