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BiSeptol Junior Spray 20ml, RO

by Medical Brands Developments BV EUDAMED

Active European Union

Ref 20TSEE.CP.ROModel Cough Treatment Spray

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number872064894040HG Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EPT 0477.MDR.25/5700 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0477
    Issued
    21 Jan 2025
    Expires
    20 Dec 2027

Specification

EUDAMED

Model / Reference
Cough Treatment Spray, 20TSEE.CP.RO
Primary DI / UDI-DI
05940541562139
Basic UDI-DI
872064894040HG
EMDN Code
G0499 Orally administered gastrointestinal devices - other
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000002672

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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