Iskra Medical, d.o.o.
Company-provided description, not an official-source fact. Certifications, capacities, years and market positions stated in it are the company's own claims until a record below confirms them.
Slovenian industrial manufacturer and exporter
Iskra Medical, d.o.o. is listed by Sloexport in the other manufacturing sector. Its directory profile describes operations including Iskra Medical is the leading Slovenian producer of devices for physiotherapy, rehabilitation and aesthetic.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer (official record)
- Location
- Podnart, Slovenia
- Website
- https://iskramedical.eu
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies
Listed in a source registry
What is established and what is not
No researcher review has been written for this company yet. 2 official records from 2 official sources are on file. Everything is listed below with its evidence type: each entry confirms only what it literally says; none of them is a review. The manufacturing role above rests on the official records listed below, and only as far as each literally goes: a facility registration or licence is not an observation of current production. Nothing here confirms ownership or trading status beyond what each record literally says.
Facts on file, each with its evidence type
- Registered as a manufacturer (record type: registered-manufacturer) [official record; status green] Its own declared activity in the register covers making these goods. checked 2026-10-17. ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- product-authorised-for-sale-holder (record type: product-authorised-for-sale-holder) [official record; status green] Applicant to the US FDA for 1 medical devices: ISKRA MEDICAL GREEN IRF PRESTIGE (K083590, 2009-04-17). The applicant answers for the notification; the record does not say who makes the device. A national regulator lists this company as the holder of the registration of products it has authorised for sale in that country. The holder answers for the product on that market; the record does not say the holder makes it. effective since 2026-10-05. FDA premarket notifications 510(k) and De Novo (openFDA, U.S. Food and Drug Administration)
Relationships
1 relationship(s) on file. Each line names the other party, the relationship as its source records it, and the source. A record of a relationship is not a finding about control beyond what it literally says.
Candidates, not confirmed
- iskramedical.eu: Website of this business. Source record
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)
Goods family established: Medical & Healthcare Supplies (the company's own text). The exact product, operation and trade route needed to determine a product-specific requirement are not established here. Product-specific import rules not established for the catalog category Pharmaceutical Manufacturing: no record or company text names goods of this kind. A catalog category alone is our classification, not proof of what the company makes or sells.