Iskra Medical, d.o.o.
Sloveense industriële fabrikant en exporteur
Iskra Medical, d.o.o. wordt door Sloexport vermeld in de overige maaksector. Het directoryprofiel beschrijft activiteiten, waaronder Iskra Medical, de toonaangevende Sloveense producent van apparaten voor fysiotherapie, revalidatie en esthetiek.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Podnart, Slovenia
- Website
- https://iskramedical.eu
- Categories
- Farmaceutische productie, Medische en gezondheidszorgbenodigdheden
- Markets
- Slovenië, Oostenrijk, Duitsland, Italië, Kroatië
Listed in a source registry
What is established and what is not
No facet of this company has been investigated yet. The facts below are collected records, not an assessment: nothing here confirms manufacturing, ownership or trading status beyond what each record literally says.
Verified facts
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)