FDA device listing
NEUROPEN,NEUROTIP
FDA device listing 1721666939 · OWEN MUMFORD LTD.
Key facts
| Proprietary names | NEUROPEN,NEUROTIP |
|---|---|
| Owner/operator | OWEN MUMFORD LTD. |
| Owner/operator number | 8021764 |
| Product codes | GXB |
| Device names | GXB - Esthesiometer |
| Device class | Class I |
| Classification regulations (21 CFR) | 882.1500 |
| Review panels | Neurology |
| Registered establishments | Owen Mumford Limited, Owen Mumford Sdn Bhd, OWEN MUMFORD USA, INC. |
| Establishment registrations | 1058602, 3003348846, 3013143994 |
| FEI numbers | 1000219614, 3003348846, 3013143994 |
| Establishment operations | Complaint File Establishment, Foreign Private Label Distributor, Repackager/Relabeler, 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