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Sophysa SPVA-140-SX

by Sophysa SA

Ref SPVA-140-SX

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760124131741 Basic UDI-DI 03760124131741UDI-DIDate26 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760124131741 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Polaris® Spv-140 Adjustable Valve / Antechamber EUDAMED
Sophysa GUDID
Generic name
Cerebrospinal fluid shunt valve
Device name
POLARIS® ADJUSTABLE VALVE 10-140 WITH ANTECHAMBER AND SiphonX®
Model / reference
SPVA-140-SX
Primary DI / UDI-DI
03760124131741
Basic UDI-DI
B-03760124131741
FDA product code
JXG
EMDN code
N01038099 Intracranial drainage devices and kits - accessories - other
GMDN term
Cerebrospinal fluid shunt valve
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5550
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Related devices

Category: Cerebrospinal fluid shunt valve

Other devices from Sophysa SA

See all devices from Sophysa SA →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number

Other properties (19)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No