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Sway System

by Sway Medical Inc

Ref Version 6Model Sway System

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number008681680003sportsD3 Basic UDI-DI 00868168000306UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00868168000306 UDI-DI Date13 Apr 2026ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Sway System EUDAMED
Sway GUDID
Generic Name
Cognitive assessment software
Model / Reference
Sway System EUDAMED
Version 6 EUDAMED
Sway Sports Plus GUDID
Primary DI / UDI-DI
00868168000306
Basic UDI-DI
008681680003sportsD3
510(k) Number
FDA Product Code
POM, LXV
EMDN Code
Z12109092 Various neurology and neurosurgery instruments - medical device software
GMDN Term
Cognitive assessment software
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1471
Special Device Type
Software
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Sway System
Version 6
GUDID
Sway Sports Plus
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000058050
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Sway Medical, Inc.

Properties

  • Prescription Use
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No