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.
Adler Ortho
Cormano, Italy
Milan-area company designing and producing joint prostheses and orthopaedic devices, many made by 3D printing.
Asa Dental
Massarosa, Italy
Tuscan manufacturer of dental instruments with a global network of offices and warehouses.
B&B Dental
Italy
Italian company that designs, produces and markets dental implants.
BART MEDICAL
Ravenna, Italy
Ravenna manufacturer of thermoforming machines and thermoplastic sheets for orthodontics.
Bioactiva
Vicenza, Italy
Vicenza company producing and marketing medical devices for oral surgery.
Biologitech
Peschiera Borromeo, Italy
Milan-area company designing and producing dental implant systems and implantology services.
Bioteck
Arcugnano, Italy
Vicenza company developing and producing biological tissue substitutes for dental, maxillofacial and orthopaedic surgery.
C-Tech Implant
Italy
Italian producer of dental implants and mini implants with conical connection.
Cattani
Parma, Italy
Parma producer of suction and compression systems and dental equipment, serving the profession since 1967.
Citieffe
Calderara di Reno, Italy
Bologna-area company developing, producing and selling orthopaedic trauma devices for internal and external fixation since 1962.
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.
Delta Med
Viadana, Italy
Mantua-area producer of intravenous catheters and medical devices, offering OEM contract production.
Dental Leader
Italy
Italian distributor of products and equipment for dentists and dental technicians.
Dental Tech
Misinto, Italy
Monza-Brianza company designing, producing and marketing its own dental implant systems.
Dental Today
Italy
Italian online supplier of dental products, consumables and professional supplies for dentists.
Dental World
Molfetta, Italy
Puglia company producing and distributing dental products in Italy and abroad since 2002.
Dentalfarm
Turin, Italy
Turin producer of dental equipment for practices and laboratories since 1972.
DIAMIR
Resia, Italy
Friuli company producing diamond burs for dentistry in Italy since 1983.
Dispotech
Gordona, Italy
Sondrio-area designer and producer of single-use and reusable medical devices, including private label.
E.C.S.
Brivio, Italy
Lecco-area designer and producer of sterilisation packaging and systems since 1995.
Effegi Brega
Sarmato, Italy
Piacenza-area builder of professional equipment for dental laboratories, sold in 30+ countries.
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.