GEBR. BRASSELER GMBH & CO. KG
- Type
- Manufacturer
- Location
- LEMGO North Rhine-Westphalia, Germany
- Categories
- Dental Supplies & Equipment, Medical & Healthcare Supplies
Listed in a source registry
Verified facts
- registered-manufacturer (green), checked 2026-08-21 ALIMS (Medicines and Medical Devices Agency of Serbia), register of medical-device manufacturers
- standards-mark-certified (green), checked 2026-08-16 EAEU unified register of certificates and declarations
- debarment-clear (green), checked 2026-08-15 OpenSanctions
- sanctions-clear (green), checked 2026-08-15 OpenSanctions
- lei-active (green), checked 2026-08-23 GLEIF global LEI register (golden copy)
- export-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
- aeo-certified (green), checked 2026-08-16 EU AEO register (European Commission)
- facility-registered (green), checked 2026-08-07 US FDA device establishment registration (openFDA)
Claimed certifications
- EAC mark (EAEU conformity) EAEU unified register of certificates and declarations
- AEO, Authorised Economic Operator EU AEO database
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)