Theo Manufacturing B.V.
We are partner for contract manufacturing solutions based in The Netherlands – Europe. We also offer European Authorised Representative service for Medical Devices. We can help you to manage your business in Europe.
European Authorized Representative
for
Medical Devices
Production potential based in Europe. Your gateway to seamless beginnings and expansions
We help non-EU manufacturers
of Medical Devices with:
- Consulting on European Regulations
- Transparent fee schedule
- Assisting in completing notifications to European Authorities
- Safeguarding and ensuring compliance with EU law
Level 1 (€ 35/h)
Postal service, telephone service and administrative service .
Level 3 (€ 200/h)
Technical file preparation and review service.
Level 2 (€ 90/h)
Advisory service.
Annual registration fee of € 1.800,00 per company.
We offer manufacturing services based in The Netherlands:
- Cleanroom class 8-7
- ISO 13485
- Mixing equipment up to 400 kg
- Filling equipment
- Full automatic packaging of alu-tubes