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POLE ELECTRODE PEN TYPE A4.Pen

by Tens Plus Industrial Company

Ref CD2473

POLE ELECTRODE PEN TYPE A4.Pen is an external manual massager (EU MDR Class I; FDA Class I; FDA product code KNM, Device, Pressure Applying) made by Tens Plus Industrial Company, registered in EUDAMED on 11 May 2026 (Basic UDI-DI 489707672CABSA) and listed in FDA GUDID since 14 Nov 2022 (UDI-DI 14897076721136), active as of 25 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number489707672CABSA Basic UDI-DI 14897076721136UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14897076721136 UDI-DI Date14 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 489707672CABSA registered 11 May 2026 Active
  • FDA GUDID UDI-DI 14897076721136 listed 14 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 14897076721136
  2. Registered EUDAMED 489707672CABSA

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Pole Electrode Pen Type
Generic name
External manual massager, clinical
Device name
Hand Poles
Model / reference
CD2473 EUDAMED
A4.Pen GUDID
Primary DI / UDI-DI
14897076721136
Basic UDI-DI
489707672CABSA
FDA product code
KNM
EMDN code
N010201 Tens system electrodes
GMDN term
External manual massager, clinical
Device class
Class I
Regulation number
890.5765
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
CD2473
GUDID
A4.Pen

Related devices

Category: External manual massager, clinical

Similar devices in this category

Other devices filed under TENS SYSTEM ELECTRODES.

Other devices from Tens Plus Industrial Company

See all devices from Tens Plus Industrial Company →

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (23, all answered No)