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Sophysa SM8-2010

by Sophysa SA

Ref SM8-2010

Sophysa SM8-2010 is a device classified as Class III in the EU and Class II in the US made by Sophysa SA, registered in EUDAMED on 2 Jun 2026 (Basic UDI-DI B-03760124131123), cleared under FDA 510(k) K013488 on 27 Mar 2002 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 03760124131123), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K013488

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760124131123 Basic UDI-DI 03760124131123UDI-DIDate2 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760124131123 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK013488 Date27 Mar 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03760124131123 registered 2 Jun 2026 Active
  • FDA 510(k) K013488 decided 27 Mar 2002 Active
  • FDA GUDID UDI-DI 03760124131123 listed 16 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K013488
  2. Listed FDA GUDID 03760124131123
  3. Registered EUDAMED B-03760124131123

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Sophy® SM8 Kit Preattached/ BO19-10 EUDAMED
Sophysa GUDID
Generic name
Ventriculo-peritoneal/atrial shunt
Model / reference
SM8-2010
Primary DI / UDI-DI
03760124131123
Basic UDI-DI
B-03760124131123
510(k) Number
FDA product code
JXG
EMDN code
N01038099 Intracranial drainage devices and kits - accessories - other
GMDN term
Ventriculo-peritoneal/atrial shunt
Device class
Class III EUDAMED
Class II GUDID
Regulation number
882.5550
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
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

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ventriculo-peritoneal/atrial shunt

Cleared under the same submission (K013488)

and 8 more cleared under K013488

Similar devices in this category

Other devices filed under INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER.

Other devices from Sophysa SA

See all devices from Sophysa SA →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)