FDA device listing
Band-Aid,Biatain Adhesive,Biatain Non-Adhesive,Biatain Silicone,Biatain Silicone Fit,Biatain Silicone Lite,Biatain…
FDA device listing 1554983951 · Coloplast Corp.
Key facts
| Proprietary names | Band-Aid,Biatain Adhesive,Biatain Non-Adhesive,Biatain Silicone,Biatain Silicone Fit,Biatain Silicone Lite,Biatain Silicone Non-Border,Biatain Soft-Hold,Biatain Super,Brava Protective Sheets,Comfeel Plus,Comfeel Plus Contour,Comfeel Plus Transparent,Compeed,Mederma,Neutrogena Sensitive Skin Blemish Patches,Neutrogena Sensitive Skin Mini Acne Patches,Neutrogena Sensitive Skin Nose… |
|---|---|
| Owner/operator | Coloplast Corp. |
| Owner/operator number | 8010144 |
| Product codes | NAD |
| Device names | NAD - Dressing, Wound, Occlusive |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4020 |
| Review panels | General & Plastic Surgery |
| Registered establishments | COLOPLAST A/S, Coloplast A/S - Mordrup Site, Coloplast Hungary, KFT, COLOPLAST HUNGARY KFT, Coloplast Manufacturing US, LLC. |
| Establishment registrations | 9610694, 3006606901, 3008262278, 3011307048, 3030087693 |
| FEI numbers | 3002806731, 3006606901, 3008262278, 3011307048, 3030087693 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler, 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