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Kit PENS 2 Aghi e Set - con via infusiva

by Advanced Medical Systems Group S.R.L. 4 variants

Ref AMS/2BPPSK-2135IL

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number805424725KITPENSRU Basic UDI-DI 08054247254001UDI-DIDate9 Oct 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Kit Pens
Model / Reference
AMS/2BPPSK-2135IL
Primary DI / UDI-DI
08054247254001
Basic UDI-DI
805424725KITPENSRU
EMDN Code
N0199 Encephalic and peripheral nervous system devices - other
Device Class
Class IIa
Medical Purpose
Il kit PENS viene impiegato nelle procedure PENS (Stimolazione elettrica dei Nervi Periferici) in associazione al generatore d’impulsi i-STIM. La terapia PENS prevede il posizionamento dell’ago bipolare i-PROBE a livello sottocutaneo, in corrispondenza dei trigger dolorosi. La conseguente erogazione di segnale a basso voltaggio ha l’esclusivo scopo di inibire la trasmissione del dolore neuropatico periferico creando un effetto analgesico. Questa procedura mini-invasiva è indicata per i seguenti trattamenti: •Trattamento neuropatico cronico periferico; •Trattamento neuropatico nocicettivo resistente alle terapie convenzionali; •Dolore post-chirurgico cronico; •Cervicalgia; •Cefalea; •Dolore muscolare (mio-fasciale) riscontrabile sia a riposo che in movimento; •Nevralgia occipitale/sopraorbitale/toracica; •Neuropatia post-erpetica; •Dolore da “arto fantasma” •Nevralgia del trigemino

Manufacturer details

EUDAMED SRN
IT-PR-000058313

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Properties

Other properties (1)

  • Sterile: No