Medicale gaze
突尼斯医疗器械出口商
Medicale Gaze 列于 CEPEX 突尼斯出口商目录中的 Dispositifs médicaux 下。官方简介标识了位于 Ben Arous 的公司并链接了此处使用的公司域名。
- Type
- Manufacturer
- Location
- Ben Arous, Tunisia
- Founded
- 1987
- Website
- https://medicale-gaze.com
- Categories
- 医疗保健用品, 药品制造
- Markets
- 突尼斯, 法国, 德国, 意大利
Listed in a source registry
Verified facts
- domain-registered (green), checked 2026-08-09 Domain registry record
- debarment-clear (green), checked 2026-08-09 OpenSanctions
- corporate-mail-on-domain (green), checked 2026-08-09 Mail server of the company domain
- sanctions-clear (green), checked 2026-08-09 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)
- 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)