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Sphera Duo Adult Unishunt

by Hp Bioproteses Ltda EUDAMED

Active European Union

Ref UADM12015D

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07898497042275 Basic UDI-DIDate24 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Hydrocephalus Valve Sphera Duo Adult size Medium pressure pre-assembled to Peritoneal Catheter 120cm, Straight Ventricular Cerebral Catheter 15cm
Model / Reference
UADM12015D
Primary DI / UDI-DI
07898497042275
Basic UDI-DI
B-07898497042275
EMDN Code
N010301 Ventricular-peritoneal shunts
Device Class
Class III
Market of Registration
Belgium

Manufacturer details

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

Other devices from Hp Bioproteses Ltda

See all devices from Hp Bioproteses Ltda →

Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No