Facility
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3002806910 |
|---|---|
| Establishment type | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | 31 CH. DE LA VUARPILLIERE NYON Vaud, CH CH-1260 |
| Registration status | Active · expires 2026 |
| Parent company | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. (owner-operator 9057430) |
| Brand names | AIR-FLOW HANDY 3 PERIO |
Devices registered here (1)
- Handpiece, Air-Powered, DentalProduct code EFB · Class I · Dental · 21 CFR 872.4200
Recalls & enforcement
- Class IIOngoing2024-03-13Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Related
- All facilities operated by E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
- E.M.S. ELECTRO MEDICAL SYSTEMS S.A. (CH)
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-15. Verify this facility record at FDA →
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