ECOM RUŠE- inženiring, proizvodnja, storitve in trgovina d.o.o.
Slovenian industrial manufacturer and exporter
ECOM RUŠE- inženiring, proizvodnja, storitve in trgovina d.o.o. is listed by Sloexport in the machining and metalworking sector. Its directory profile describes operations including We manufacture equipment in stainless steel and special materials, the paper, pharmaceutical, chemical and food industries, wastewater cleaning.
- Type
- Manufacturer
- Location
- Ruše, Slovenia
- Website
- https://ecom.si
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies, Chemicals & Plastics
- Markets
- Slovenia, Austria, Germany, Italy, Croatia
Listed in a source registry
Verified facts
- sanctions-clear (green), checked 2026-08-12 OpenSanctions
- debarment-clear (green), checked 2026-08-12 OpenSanctions
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)
- Chemical substances imported into the EU above 1 tonne/year must be REACH-registered. ECHA (REACH)
- 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)