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Electrode Sponge

by ZMI Electronics Ltd. 7 variants

Part of a family of 26 devices: see the family page

Ref SPS-P-090105

Electrode Sponge (SPS-P-090105) is a Class I device made by ZMI Electronics Ltd., registered in EUDAMED on 24 Feb 2023 (Basic UDI-DI 471987233SPSSF), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471987233SPSSF Basic UDI-DI 04719872331681UDI-DIDate24 Feb 2023RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Electrode Sponge
Model / reference
SPS-P-090105
Primary DI / UDI-DI
04719872331681
Basic UDI-DI
471987233SPSSF
EMDN code
Z120601 Electrotherapy equipment (included tens)
Device class
Class I
EU registration type
Standard device
EU market of registration
Slovenia

Manufacturer details

EUDAMED SRN
TW-MF-000003571
Authorised representative
mdi Europa GmbH DE-AR-000006218

Similar devices in this category

Other devices filed under ELECTROTHERAPY EQUIPMENT (INCLUDED TENS).

Other devices from Zmi Elecronics, Ltd.

  • Levina PFR-01-NS

    Class II
  • Levina PFR-03-NS

    Class II
  • Levina PFR-02-NS

    Class II
  • Levina RS-48

    Class II

See all devices from Zmi Elecronics, Ltd. →

Properties

Other properties (14, all answered No)