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Sphera Duo Neonatal with Reservoir

by Hp Bioproteses Ltda EUDAMED

Active European Union

Ref NNB905RD

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07898497042749 Basic UDI-DIDate25 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Hydrocephalus Valve Sphera Duo Neonatal size Low pressure, Right Angled Ventricular Cerebral Catheter 5cm with reservoir, Peritoneal Catheter 90cm
Model / Reference
NNB905RD
Primary DI / UDI-DI
07898497042749
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BR-MF-000048434
Authorised representative
Obelis s.a. BE-AR-000000106

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