1Flex Technology
Frosinone, Italy
Frosinone company distributing dental products for technicians and dentists and producing surgical masks.
ab medica
Cerro Maggiore, Italy
Milan-area company designing and distributing healthcare solutions, including robotic surgery systems, since 1984.
Bioactiva
Vicenza, Italy
Vicenza company producing and marketing medical devices for oral surgery.
DAM (Fresissima)
Avigliana, Italy
Turin-area Italian producer of tungsten carbide instruments for dentistry.
De Marco
Milan, Italy
Milan company designing, producing and distributing dental and medical instruments and hygiene equipment.
Dental Leader
Italy
Italian distributor of products and equipment for dentists and dental technicians.
Dental World
Molfetta, Italy
Puglia company producing and distributing dental products in Italy and abroad since 2002.
GIMA
Gessate, Italy
Milan-area distributor of medical products and instruments, offering over 10,000 items to medical dealers.
Intrauma
Bruino, Italy
Turin-area company that designs and produces O'nil internal fixators and distributes orthopaedic products.
Larident
Tribogna, Italy
Genoa-area company producing and distributing dental products and hygiene and prophylaxis items since 1960.
Lascod
Italy
Italian manufacturer and distributor of dental alginates, silicones, cements and gypsums since 1946.
Meté
Arsago Seprio, Italy
Varese-area dental company whose main activity is production, complemented by marketing and distribution.
Target Ortodonzia
Garbagnate Milanese, Italy
Milan-area distributor of orthodontic products from Ortho Organizers, part of Henry Schein Orthodontics.
Business types in Italy
Cities in Italy
Medical exhibitions in Italy
Regulation in Italy
Italy is in the EU / EEA, so the EU framework applies.
Regulator: European Commission (DG SANTE) with national competent authorities of EU/EEA Member States
Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.
From the sourced EU MDR / IVDR entry, checked 29 October 2026. General information, not legal advice. Requirements for Italy · All medical certifications
Frequently asked questions
What technical documentation should an Italian manufacturer hold for an MDR instrument?
Every MDR device, including self-declared Class I devices, needs technical documentation under Annexes II and III. For an instrument this usually includes:
- a device description and specifications, labeling and IFU;
- a checklist of the General Safety and Performance Requirements, with the standards applied;
- the risk management file, biocompatibility, sterilization or reprocessing and performance test reports as relevant;
- a clinical evaluation plan and report, proportionate to risk and updated with post-market data;
- post-market surveillance documentation.
Buyers rarely receive the full file, but can ask for a summary or the GSPR checklist. Italian manufacturers are on the Italy country page; see the medical certifications page.