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Phagenyx

by Phagenesis Ltd 2 variants

Ref EPSB3

Phagenyx (EPSB3) is a pharyngeal electrical stimulation control unit (EU MDR Class IIa; FDA Class II; FDA product code QQG, Oropharyngeal Electrical Stimulator) made by Phagenesis Ltd, granted FDA De Novo DEN220025 on 16 Sep 2022, registered in EUDAMED on 2 Aug 2022 (Basic UDI-DI 506045348B039S) and listed in FDA GUDID since 3 Aug 2023 (UDI-DI 05060453480045), active as of 24 Oct 2026.

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

CE MDR De Novo

Valid until

No date given

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

De Novo DEN220025

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05060453480045 UDI-DI Date3 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG GUDID from GUDID De Novo granted · Direct NumberDEN220025 Date16 Sep 2022DecidedStatusActive
European UnionCE/MDR EUDAMED Number506045348B039S Basic UDI-DI 05060453480045UDI-DIDate2 Aug 2022RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA De Novo DEN220025 decided 16 Sep 2022 Active
  • EUDAMED Basic UDI-DI 506045348B039S registered 2 Aug 2022 Active
  • FDA GUDID UDI-DI 05060453480045 listed 3 Aug 2023 Listed

Timeline

3 dated events

  1. Registered EUDAMED 506045348B039S
  2. Granted FDA De Novo DEN220025
  3. Listed FDA GUDID 05060453480045

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA De Novo Active

Specification

EUDAMED · GUDID

Generic name
Pharyngeal electrical stimulation control unit
Device name
Phagenyx Base Station
Model / Ref / Catalog
EPSB3
Primary DI / UDI-DI
05060453480045
Basic UDI-DI
506045348B039S
Direct marketing DI
05060453480045
De Novo Number
FDA product code
QQG
EMDN code
Z12101106 Neurological stimulators
GMDN term
Pharyngeal electrical stimulation control unit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.5950
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
GB-MF-000015848
Authorised representative
Veranex Germany GmbH DE-AR-000005578

Related devices

Category: Point aesthesiometer

Similar devices in this category

Other devices filed under NEUROLOGICAL STIMULATORS.

Other devices from Phagenesis Ltd

Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)