FDA device listing
Cuticell Contact,Cutimed Cuticell,Leukomed,Leukomed I.V.,Leukomed I.V. Film,Leukomed Skin Sensitive,Leukomed T,Leukomed…
FDA device listing 2061343511 · BSN medical GmbH
Key facts
| Proprietary names | Cuticell Contact,Cutimed Cuticell,Leukomed,Leukomed I.V.,Leukomed I.V. Film,Leukomed Skin Sensitive,Leukomed T,Leukomed T plus,Leukomed T plus skin sensitive,Leukomed T skin sensitive,Leukoplast aqua pro,Leukoplast barrier,Leukoplast Elastic,Leukoplast kids,Leukoplast kids hero edition,Leukoplast soft white,Leukoplast strong |
|---|---|
| Owner/operator | BSN medical GmbH |
| Owner/operator number | 9047426 |
| 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 | BSN Medical GmbH, BSN MEDICAL GMBH, BSN medical Inc., BSN medical Limitada (COLOMBIA), Essity Distribution B.V. |
| Establishment registrations | 1038963, 9617266, 9710608, 3017297225, 3017633586 |
| FEI numbers | 1038963, 3002249650, 3003441980, 3017297225, 3017633586 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, 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