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Sphera Duo Adult Unishunt

by Hp Bioproteses Ltda 18 variants

Ref UADB12023D

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-07898497043838 Basic UDI-DI 07898497043838UDI-DIDate24 Aug 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Hydrocephalus Valve Sphera Duo Adult size Low pressure pre-assembled to Peritoneal Catheter 120cm, Straight Ventricular Cerebral Catheter 23.5cm
Model / Reference
UADB12023D
Primary DI / UDI-DI
07898497043838
Basic UDI-DI
B-07898497043838
EMDN Code
N010301 Ventricular-peritoneal shunts
Device Class
Class III
EU market of registration
Belgium

Manufacturer details

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

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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