Certification

Macopharma is an approved pharmaceutical laboratory that applies Good Manufacturing Practices (GMP) .

All of our medical devices feature the CE marking and meet the fundamental requirements of European directive 93/42/EEC.

Some of our blood filtration systems are approved by the United States Food and Drug Administration (FDA).

CE Certificates

The THERAFLEX MB-Plasma is registered in Europe as a Class III medical device and is certified by the LNE/G-Med.

ISO Certificates

The THERAFLEX MB-Plasma is produced to the ISO 13485:2016 qualité standard as certified by LNE/G-Med. The French production site in Tourcoing has received in 2012 the ISO 14001:2015.

Contactez nous

Macopharma Tourcoing

200 Chaussée Fernand Forest
59200 Tourcoing - FRANCE
Tel : +33 (0) 3 20 11 84 00
Fax : +33 (0) 3 20 11 84 03

Pharmacovigilance France

Tel : +33 (0) 3 20 11 84 00
24 days / 24 - 7 days / 7

Matériovigilance Dpt

Tel : +33 (0) 3 20 11 84 00
Tel : +33 (0) 6 63 30 55 65

Pour consulter la liste complète des contacts, veuillez cliquer ici