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Cefaly® CEFALY DUAL Enhanced

by Cefaly Technology SPRL

Ref 10602,10603, 10604, 10605, 10606 , 10607 ,10608 ,10609,Model 10602,10603,10604,10605,10606,10607,10608,10609,

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05425018850273 Basic UDI-DI 05425018850273UDI-DIDate5 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05425018850273 UDI-DI Date17 May 2021ListedStatusListed 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 23 Oct 2026.

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  • Withdrawn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
Cefaly EUDAMED
Cefaly® GUDID
Generic Name
Craniofacial analgesia electrical stimulator
Device Name
CEFALY Enhanced
Model / Ref / Catalog
10602 EUDAMED
10603 EUDAMED
10604 EUDAMED
10605 EUDAMED
10606 EUDAMED
10607 EUDAMED
10608 EUDAMED
10609 EUDAMED
CEFALY DUAL Enhanced GUDID
10601 GUDID
Primary DI / UDI-DI
05425018850273
Basic UDI-DI
B-05425018850273
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
10602,10603,10604,10605,10606,10607,10608,10609,
10602,10603, 10604, 10605, 10606, 10607,10608,10609,
GUDID
CEFALY DUAL Enhanced
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Over-the-Counter
  • Serial Number
  • Expiration Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No