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Pari O-Pep

by PARI GmbH Spezialisten für effektive Inhalation 5 variants

Ref 018G5005Model PARI O-PEP

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, self-declared

Class I: no certifier involved

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 Number426002043-P018-5000-00LW Basic UDI-DI 04251855902964UDI-DIDate27 Nov 2025RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Pari O-Pep
Model / Reference
PARI O-PEP, 018G5005
Primary DI / UDI-DI
04251855902964
Basic UDI-DI
426002043-P018-5000-00LW
EMDN Code
R900902 Inspiratory and expiratory flow stimulators/respiratory muscles trainers
Device Class
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000006567

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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