Iskra Medical, d.o.o.
슬로베니아 산업 제조업체 및 수출업체
Iskra Medical, d.o.o. Sloexport에 의해 기타 제조 부문에 상장되어 있습니다. 디렉토리 프로필에는 Iskra Medical이 슬로베니아의 물리치료, 재활 및 미용용 장치를 생산하는 선도업체임을 포함하여 운영이 설명되어 있습니다.
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Podnart, Slovenia
- Website
- https://iskramedical.eu
- Categories
- 의약품 제조, 의료 및 건강 관리 용품
- Markets
- 슬로베니아, 오스트리아, 독일, 이탈리아, 크로아티아
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)