FDA device listing
Gengigel Gel 20ml,Gengigel Gel Junior 15ml,Gengigel Hydrogel 150ml,Gengigel Hydrogel 300ml,Gengigel Spray 20ml
FDA device listing 1313075558 · Betafarma S.p.A
Key facts
| Proprietary names | Gengigel Gel 20ml,Gengigel Gel Junior 15ml,Gengigel Hydrogel 150ml,Gengigel Hydrogel 300ml,Gengigel Spray 20ml |
|---|---|
| Owner/operator | Betafarma S.p.A |
| Owner/operator number | 10090690 |
| Product codes | OLR |
| Device names | OLR - Oral Wound Dressing |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.OLR |
| Review panels | Dental |
| Registered establishments | BETAFARMA S.P.A |
| Establishment registrations | 3004985762 |
| FEI numbers | 3004985762 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database