CE-MED d.o.o.
斯洛文尼亚工业制造商和出口商
CE-MED d.o.o.被 Sloexport 列入其他制造业领域。其目录配置文件描述了包括 CE-MED D.O.O. 在内的操作。佛山市科恩医疗器械有限公司成立于2009年12月30日，公司主要利用优质材料和自有生产能力研发和生产医疗器械；因此，我们努力满足养老院、医院、门诊诊所、疗养胜地适用的现代护理的所有要求。
- Type
- Manufacturer
- Location
- Štore, Slovenia
- Website
- https://ce-med.si
- Categories
- 药品制造, 医疗保健用品, 电力及电力设备
- Markets
- 斯洛文尼亚, 奥地利, 德国, 意大利, 克罗地亚
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)