Iskra Medical, d.o.o.
斯洛文尼亚工业制造商和出口商
Iskra Medical，d.o.o.被 Sloexport 列入其他制造业领域。其目录简介描述了包括 Iskra Medical 在内的业务，Iskra Medical 是斯洛文尼亚领先的物理治疗、康复和美容设备生产商。
- Type
- manufacturer (our classification of the record, not a statement by the company)
- Role
- Manufacturer
- Location
- Podnart, Slovenia
- Website
- https://iskramedical.eu
- Categories
- 药品制造, 医疗保健用品
- Markets
- 斯洛文尼亚, 奥地利, 德国, 意大利, 克罗地亚
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)