FDA device listing
MediPlus Barrier-Gel,MediPlus Barrier-Gel Comfort,MediPlus GelTube
FDA device listing 1190304481 · MEDIPURPOSE PTE LTD
Key facts
| Proprietary names | MediPlus Barrier-Gel,MediPlus Barrier-Gel Comfort,MediPlus GelTube |
|---|---|
| Owner/operator | MEDIPURPOSE PTE LTD |
| Owner/operator number | 9036485 |
| Product codes | NAE |
| Device names | NAE - Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4022 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MEDIPURPOSE PTE. LTD. |
| Establishment registrations | 9614157 |
| FEI numbers | 3008179438 |
| Establishment operations | Foreign Exporter, Specification Developer |
| 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