FDA device listing
Silicon Scar Sheets/Silicone Tape
FDA device listing 1181107967 · Ningbo Risenmed Technology Co.,Ltd.
Key facts
| Proprietary names | Silicon Scar Sheets/Silicone Tape |
|---|---|
| Owner/operator | Ningbo Risenmed Technology Co.,Ltd. |
| Owner/operator number | 10085370 |
| Product codes | PFP |
| Device names | PFP - Silicone Hydrogel For Scar Management |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4025 |
| Review panels | General & Plastic Surgery |
| Registered establishments | NINGBO RISENMED TECHNOLOGY CO.,LTD. |
| Establishment registrations | 3023339256 |
| FEI numbers | 3023339256 |
| Establishment operations | 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