FDA device listing
ALLDRESS,Exufiber,Melgisorb Plus,Mepilex,Mepilex Border,Mepilex Border Flex,Mepilex Border Flex Lite,Mepilex Border…
FDA device listing 1341643336 · MOLNLYCKE HEALTH CARE US LLC
Key facts
| Proprietary names | ALLDRESS,Exufiber,Melgisorb Plus,Mepilex,Mepilex Border,Mepilex Border Flex,Mepilex Border Flex Lite,Mepilex Border Heel,Mepilex Border Lite,Mepilex Border Post Op,Mepilex Border Sacrum,Mepilex Heel,Mepilex Lite,Mepilex Transfer,Mepilex Up,Mepilex XT,MEPORE,Mepore Film and Pad,Mepore Pro,Mepore Roll,MESALT,Mesorb,Mestopore,Mestopore S,Mextra Superabsorbent |
|---|---|
| Owner/operator | MOLNLYCKE HEALTH CARE US LLC |
| Owner/operator number | 8030877 |
| Product codes | NAC |
| Device names | NAC - Dressing, Wound, Hydrophilic |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4018 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MOLNLYCKE HEALTH CARE, Molnlycke Health Care AB, Molnlycke Health Care Oy, MOLNLYCKE HEALTH CARE (THAILAND), LTD., MOLNLYCKE MANUFACTURING US, LLC |
| Establishment registrations | 8020673, 3006607005, 3007048057, 3007605720, 3010099071 |
| FEI numbers | 2819, 3006607005, 3007048057, 3007605720, 3010099071 |
| Establishment operations | Manufacturer, 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