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E.M.S. Electro Medical Systems S.A.

Switzerland CH-MF-000026136 Last updated 25 Oct 2026

Devices
32
Registries
EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue32

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

Notified body 0124 1 certificate

  • 50081-60-01-00 Reissued

    Quality management system EU MDR

    Issued
    18 Jun 2025
    Expires
    17 Jun 2030

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Authorised representatives

Notified bodies

  • Notified body 0124

What E.M.S. Electro Medical Systems S.A. makes

E.M.S. Electro Medical Systems S.A. manufactures dental ultrasonic devices, including piezoelectric surgical tools like the PIEZON 150, PIEZON 250, and PIEZON MASTER 700 series for precision bone surgery. Their portfolio also includes air-polishing systems such as the EMS AIRFLOW Prophylaxis Master and AIR-FLOW handy 3.0 PLUS for periodontal cleaning. Shock wave therapy devices like the DolorClast Radial and DOLORCLAST Focused Shock Waves are designed for musculoskeletal treatments, while the Swiss LithoClast Trilogy is used for lithotripsy in dental and urological applications.

The company’s devices are classified under EU regulations as Class I, Class II, and Class IIa, with listings in the EUDAMED database and FDA’s 510(k) clearance registry. The manufacturer is based in Switzerland and adheres to relevant regulatory frameworks for medical devices in both the European Union and the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does E.M.S. Electro Medical Systems S.A. manufacture?

E.M.S. Electro Medical Systems S.A. specializes in dental and musculoskeletal medical devices. Their portfolio includes ultrasonic piezoelectric surgical tools like the PIEZON series, which are used for precision bone surgery in dentistry. They also produce air-polishing systems such as the EMS AIRFLOW range for periodontal cleaning and shock wave therapy devices like the DolorClast series for treating musculoskeletal conditions. Additionally, they offer lithotripsy devices like the Swiss LithoClast Trilogy, which are used for breaking up stones in dental and urological applications.

Where is E.M.S. Electro Medical Systems S.A. based?

E.M.S. Electro Medical Systems S.A. is headquartered in Switzerland. The company operates within the regulatory frameworks of both the European Union and the United States, ensuring compliance with medical device standards in these regions.

Which regulatory registries list E.M.S. Electro Medical Systems S.A.’s devices?

E.M.S. Electro Medical Systems S.A.’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. Their devices are also included in the FDA’s 510(k) clearance registry, demonstrating compliance with U.S. medical device regulations.

How are E.M.S. Electro Medical Systems S.A.’s devices classified under EU regulations?

Under EU medical device regulations, E.M.S. Electro Medical Systems S.A.’s devices are classified as Class I, Class II, and Class IIa. The classification depends on factors like the intended use, risk level, and interaction with the body. For example, piezoelectric surgical tools like the PIEZON series are typically Class IIa due to their surgical application, while air-polishing systems like the EMS AIRFLOW range may fall under Class II or Class I depending on their specific design and risk profile.

What is the primary purpose of the Swiss LithoClast Trilogy and DolorClast devices manufactured by E.M.S. Electro Medical Systems S.A.?

The Swiss LithoClast Trilogy is designed for lithotripsy, which is the process of breaking up stones (such as kidney or bladder stones) using shock waves, enabling their safe removal from the body. The DolorClast devices, including the Radial and Focused Shock Waves models, are intended for musculoskeletal treatments, such as pain relief and tissue regeneration, by delivering targeted shock waves to affected areas.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Switzerland(from SRN)
Address
31, Chemin de la Vuarpillière, Nyon, Switzerland
Phone
+41229944700
PRRC contact
Céline Delannoy
EUDAMED SRN
CH-MF-000026136
FDA FEI number
3004096429