FDA Registration
Active
🇨🇭 Switzerland
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
Reg #: 8030987
·
FEI: 3002806910
·
Expires 2026
Products
14
Proprietary Names
29
Establishment Types
4
Classifications
14
Registration Details
- Registration Name
- E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
- Registration Number
- 8030987
- FEI Number
- 3002806910
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 31 CH. DE LA VUARPILLIERE
- City
- NYON Vaud
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K191124
- PMA Number
- P050004
Owner / Operator
- Firm Name
- E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
- Operator Number
- 9057430
- Address
- 31 CH. DE LA VUARPILLIERE, --
- City
- NYON, VAUD
- State
- CH-NOTA
- Postal Code
- CH-1260
- Country
- CH
- Correspondent
- S. - FASSIO-HARDY
US Agent
- Business Name
- ELECTRO MEDICAL SYSTEMS, L.L.C.
- Contact Name
- JEAN BAPTISTE AMADIEU
- Address
- 2150 E Continental Blvd
- City
- Southlake
- State
- TX
- ZIP
- 76092
- Country
- US
- [email protected]
- Phone
- 972 6908382 ext. 104
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lithotriptor, Ultrasonic | FEO | Class 2 | Gastroenterology, Urology | No | 2019-07-10 |
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2019-07-10 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2018-03-14 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2019-11-04 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-05-06 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2022-09-06 |
| Airbrush | KOJ | Class 2 | Dental | No | 2026-01-29 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2018-03-14 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2023-03-21 |
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | PZL | Class 2 | General, Plastic Surgery | No | 2025-08-28 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2007-12-21 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2013-01-23 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2023-12-04 |
| Generator, Shock-Wave, For Pain Relief | NBN | Class 3 | Unknown | No | 2007-08-23 |
Proprietary Names
SWISS LITHOCLAST TRILOGY
PERIO-FLOW NOZZLE
AIR-FLOW HANDY 3 PERIO
OSSTEM BIK
Probe dia. 3.2 x 425 mm (9,6 Ch.) and SWISS LITHOCLAST MASTER Pneumatic Handpiece
PIEZON BIK
AIR-FLOW HANDY 2+
EMS SmartFibers
DolorClast Radial
GBT Machine Airflow Prophylaxis Master
SWISS LITHOCLAST SELECT
SWISS LITHOCLAST ULTRA
AIRFLOW PLUS POWDER
AIR-FLOW HANDY 3
GBT FLOW CONTROL
LaserClast TM Fiber
LASERCLAST35
AIRFLOW PROPHYLAXIS MASTER, AIRFLOW ONE
PIEZON 250
DOLORCLAST Focused Shock Waves
AIR-FLOW POWDER
PIEZON MASTER SURGERY
Lithovac lv3 Set
GBT VISIGATE
Swiss LithoClast Trilogy System Kit - US
Swiss LithoClast Trilogy Max System Kit
PIEZON
Swiss DolorClast
SWISS LITHOBREAKER
Establishment Types
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device