FDA device listing
Collagen Mask, Lip Mask, Sheet Mask; Cream Masks; Ear Candle, Konjac Sponge, Jelly Mask,Hydrocolloid Roll; Pimple…
FDA device listing 2060513970 · Zhengzhou Boma Biotech Co.,Ltd
Key facts
| Proprietary names | Collagen Mask, Lip Mask, Sheet Mask ; Cream Masks; Ear Candle, Konjac Sponge, Jelly Mask,Hydrocolloid Roll; Pimple Patch; Acne Patch; Hydrocolloid Dressing, Gel Patch; Eye Patch;Eye Mask; Facial Mask |
|---|---|
| Owner/operator | Zhengzhou Boma Biotech Co.,Ltd |
| Owner/operator number | 10094394 |
| 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 | ZHENGZHOU BOMA BIOTECH CO.,LTD |
| Establishment registrations | 3042276434 |
| FEI numbers | 3042276434 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| 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