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Spiro-Ball Adult 4000ml Blue

by Pecmed EUDAMED

Active European Union

Ref L25913002Model SPIROBALL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number61923410PM001CD Basic UDI-DIDate19 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

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

Specification

EUDAMED

Model / Reference
SPIROBALL, L25913002
Primary DI / UDI-DI
06192341000048
Basic UDI-DI
61923410PM001CD
EMDN Code
R900902 Inspiratory and expiratory flow stimulators/respiratory muscles trainers
Device Class
Class I
Market of Registration
France

Manufacturer details

EUDAMED SRN
TN-MF-000040887
Authorised representative
HYDREX INTERNATIONAL FR-AR-000002216

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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