Facility
DELTA MED SPA
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3004967767 |
|---|---|
| Establishment type | Manufacture Medical Device for Another Party (Contract Manufacturer); Manufacture Medical Device |
| Location | Strada Provinciale per Dubino 10 Delebio Sondrio, IT 23014 |
| Registration status | Active · expires 2026 |
| Parent company | DELTA MED SPA (owner-operator 9069475) |
| Brand names | FOLEY MANOMETER LV |
Devices registered here (1)
- Device, Cystometric, HydraulicProduct code FEN · Class II · Gastroenterology, Urology · 21 CFR 876.1620
Recalls & enforcement
- Class IIOngoing2021-06-21Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
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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