Facility
EMPATICA S.r.l.
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3012933969 |
|---|---|
| Establishment type | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Via Enrico Stendhal 36 Milano, IT 20144 |
| Registration status | Active · expires 2026 |
| Parent company | Empatica (owner-operator 10058838) |
Devices registered here (1)
- Physiological Signal Based Seizure Monitoring SystemProduct code POS · Class II · Neurology · 21 CFR 882.1580
Recalls & enforcement
- Class IIOngoing2023-07-13May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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