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Flow Neuroscience FL-PADS-24

by Flow Neuroscience AB EUDAMEDGUDID

Active European Union

Ref FL-PADS-24

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number731458FL-PADSWR Basic UDI-DIDate10 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07314585000007 UDI-DIDate2 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Flow Neuroscience
Generic Name
Transcranial electrical stimulation system, continuous-current, home-use
Device Name
Single Use, Non-Sterile Electrode Pads For Use Only With FL-100 or FL-150 Headset
Model / Ref / Catalog
FL-PADS-24
Primary DI / UDI-DI
07314585000007 EUDAMED
17314585010003 GUDID
Basic UDI-DI
731458FL-PADSWR
Direct Marketing DI
07314585000007
PMA Number
FDA Product Code
JXK
EMDN Code
N0199 Encephalic and peripheral nervous system devices - other
GMDN Term
Transcranial electrical stimulation system, continuous-current, home-use
Device Class
Class I EUDAMED
Class III GUDID
Regulation Number
882.5800
Market of Registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
07314585000007
GUDID
17314585010003
Device ClassEUDAMED
Class I
GUDID
Class III

Related devices

Cleared under the same submission (P230024)

Other devices from Flow Neuroscience AB

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No