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Sphera Duo Infantile (Separated Components)

by Hp Bioproteses Ltda Brazil EUDAMED

Ref INE9010D EMDN N010301

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07898497042411 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  • Withdrawn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 · synced 25 Oct 2026

Device Name
Hydrocephalus Valve Sphera Duo Infantile size Extra Low pressure, Right-Angled Ventricular Cerebral Catheter 10cm, Peritoneal Catheter 90cm
Model / Reference
INE9010D
Primary DI / UDI-DI
07898497042411
Basic UDI-DI
B-07898497042411
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 07898497042411|B-07898497042411 61 fields · synced 25 Oct 2026