FMS 4

Organization name

Iskra Medical, d.o.o., raziskave in razvoj na področju medicinske opreme in kozmetike

SRN

SI-MF-000006345

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

1 warning recorded — scroll inside the panel to see all entries.

• CW018

  • Pregnancy • Cardiac arrhythmia • Active internal medical devices e.g., cardiac pacemaker, medication pumps etc. • Epilepsy or suspected epilepsy • Ferromagnetic implants at or near the site of stimulation • Recent surgery at the site of stimulation • Thrombosis or thrombophlebitis • Active malignancy • Acute stages of kidney stones • Gastrointestinal and internal disease at the site of stimulation

Primary placement in Slovenia; available across 32 countries total.

Trade name

FMS 4

UDI-DI code

03830066952015

Basic UDI-DI

383006695FMSJ5

Reference / catalog number

MS012

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z120606MAGNETOTHERAPY EQUIPMENT