FDA Registration
Active
🇨🇭 Switzerland
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
Reg #: 3004096429
·
FEI: 3004096429
·
Expires 2026
Products
12
Proprietary Names
26
Establishment Types
3
Classifications
12
Registration Details
- Registration Name
- E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
- Registration Number
- 3004096429
- FEI Number
- 3004096429
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- RTE DE CHAMP-COLIN 2
- City
- NYON Vaud
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K173234
- 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 | 2018-01-31 |
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2018-01-31 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2017-05-22 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2007-12-21 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2019-11-04 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-05-06 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2023-12-04 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2013-01-23 |
| Generator, Shock-Wave, For Pain Relief | NBN | Class 3 | Unknown | No | 2007-08-23 |
| Airbrush | KOJ | Class 2 | Dental | No | 2026-01-29 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2022-09-06 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2023-03-21 |
Proprietary Names
SWISS LITHOCLAST TRILOGY
AIR-FLOW POWDER
AIR-FLOW HANDY 2+
OSSTEM BIK
EMS SmartFibers
Probe dia. 3.2 x 425 mm (9,6 Ch.) and SWISS LITHOCLAST MASTER Pneumatic Handpiece
AIR-FLOW HANDY 3 PERIO
GBT VISIGATE
SWISS LITHOBREAKER
LASERCLAST35
PERIO-FLOW NOZZLE
LaserClast TM Fiber
PIEZON BIK
Lithovac lv3 Set
Swiss DolorClast
AIRFLOW PLUS POWDER
AIR-FLOW HANDY 3
GBT Machine Airflow Prophylaxis Master
Swiss LithoClast Trilogy System Kit - US
Swiss LithoClast Trilogy Max System Kit
AIRFLOW PROPHYLAXIS MASTER, AIRFLOW ONE
DolorClast Radial
PIEZON 250
SWISS LITHOCLAST SELECT
SWISS LITHOCLAST ULTRA
GBT FLOW CONTROL
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Export Device to the United States But Perform No Other Operation on Device