ETOL GESUNDHEITSPFLEGE-UND PHARMAPRODUKTE GMBH
- Type
- Manufacturer
- Location
- Oberkirch Baden-Wurttemberg, Germany
- Founded
- 2016
- Categories
- Dental Supplies & Equipment
Listed in a source registry
Verified facts
- operating-permit (green), checked 2026-08-19 EudraGMDP manufacturing authorisation register (EMA)
- sanctions-clear (green), checked 2026-08-15 OpenSanctions
- debarment-clear (green), checked 2026-08-15 OpenSanctions
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- gmp-certified (green), checked 2023-07-26 EudraGMDP, EU register of GMP certificates (EMA)
- registry-active-global (green), checked 2026-08-17 Marktstammdatenregister (Bundesnetzagentur)
- registered-since (green), checked 2016-05-03 Marktstammdatenregister (Bundesnetzagentur)
Claimed certifications
- Good Manufacturing Practice
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)