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CEFALY Dual

by CEFALY Technology

Ref 10503,10504,10505,10506,10507,10508,10509,10510,10511,10512,10513,10517,10518,10519,10520,10526,10529

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

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201895↗

+2 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05425018850259 Basic UDI-DI 05425018850259UDI-DIDate31 Mar 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK201895 Date29 Sep 2020IssuedStatusActive
United StatesGUDID listing GUDID Number05425018850259 UDI-DI Date29 Nov 2017ListedStatusListed 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 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Trade Name
CEFALY Dual EUDAMED
Cefaly® GUDID
Generic Name
Craniofacial analgesia electrical stimulator
Model / Ref / Catalog
10503, 10504, 10505, 10506, 10507, 10508, 10509, 10510, 10511, 10512, 10513, 10517, 10518, 10519, 10520, 10526, 10529, Dual
Primary DI / UDI-DI
05425018850259
Basic UDI-DI
B-05425018850259
510(k) Number
FDA Product Code
PCC
EMDN Code
N010201, N010299
GMDN Term
Craniofacial analgesia electrical stimulator
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.5891
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
BE-MF-000011545

Other devices from Cefaly Technology

Properties

  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No