FDA device listing
Aroamas Silicone Scar Removal Sheets-3in*1.6 in,8 Reusable Sheets,3in*1.6 in, 4 Reusable Sheets, 5.9in*1.6 in,4…
FDA device listing 1018565435 · Henan Huibo Medical CO., LTD
Key facts
| Proprietary names | Aroamas Silicone Scar Removal Sheets-3in*1.6 in,8 Reusable Sheets,3in*1.6 in, 4 Reusable Sheets, 5.9in*1.6 in,4 Reusable,medical silicone sheet dressings,Puriderma Medical Silicone Scar Removal Sheets-1.6in*3 in,5 Reusable Sheets;5.9in*1.6 in,4 Reusable Sheets,Skintensive ScarSmart Scar Sheets 3.5 in*1.6 in,St. Mege Silicone Scar Sheets-5.9''*1.6'',4 Reusable Sheets,Tetyana Natural Silicone Scar… |
|---|---|
| Owner/operator | Henan Huibo Medical CO., LTD |
| Owner/operator number | 10053214 |
| Product codes | MDA |
| Device names | MDA - Elastomer, Silicone, For Scar Management |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4025 |
| Review panels | General & Plastic Surgery |
| Registered establishments | HENAN HUIBO MEDICAL CO., LTD |
| Establishment registrations | 3012852163 |
| FEI numbers | 3012852163 |
| Establishment operations | Contract Manufacturer, 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