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Positive Expiratory Pressure (PEP) Therapy device

by Intersurgical Ltd United Kingdom EUDAMED

Ref 8020050 EMDN Z12159009

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number05030267PEPTHERER Basic UDI-DIDate17 Oct 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Positive Expiratory Pressure (PEP) Therapy device
Model / Reference
8020050
Primary DI / UDI-DI
05030267160815
Basic UDI-DI
05030267PEPTHERER
EMDN Code
Z12159009 Equipment for removal of secretions
Device Class
Class I
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
GB-MF-000004798
Authorised representative
UAB Intersurgical LT-AR-000003907

Other devices from Intersurgical Ltd

See all devices from Intersurgical Ltd →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 2d3e4e9a-21dd-4db6-99f4-6341fe6d35de 61 fields · synced 24 Oct 2026