CE-MED d.o.o.
Slovenian industrial manufacturer and exporter
CE-MED d.o.o. is listed by Sloexport in the other manufacturing sector. Its directory profile describes operations including CE-MED D.O.O. was established at Dec. 30th 2009. Company mainly develop and produce medical equipment by using high-quality materials and our own production capacities; whereby, we strive to meet all the requirements of the applicable modern care at retirement homes, hospitals, outpatient clinics, health resorts, as we.
- Type
- Manufacturer
- Location
- Štore, Slovenia
- Website
- https://ce-med.si
- Categories
- Pharmaceutical Manufacturing, Medical & Healthcare Supplies, Electrical & Power Equipment
- Markets
- Slovenia, Austria, Germany, Italy, Croatia
Listed in a source registry
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)
- Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
- Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)