Data / Medical devices / Finland / Molnlycke Health Care Oy
Molnlycke Health Care Oy: FDA-registered device maker in Mikkeli Etela-Savo, Finland, 6 510(k) clearances
Molnlycke Health Care Oy is registered with the FDA (registration 3007605720) in Mikkeli Etela-Savo, Finland. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 1, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007605720
- Address
- Saimaankatu 6 PO Box 76, Mikkeli Etela-Savo, Finland, FI-50101
- Owner or operator
- MOLNLYCKE HEALTH CARE US LLC (8030877)
- Roles
- Manufacturer
- First device listed
- July 24, 1996
- Registered through
- 2026
- Brand names listed
- ALLDRESS, Avance Solo NPWT System, Exufiber, Exufiber Ag+, MEFILM, MEPITEL, MEPITEL ONE, MEPORE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2021 | K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) System | OMP | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| August 25, 2016 | K160379 | Exufiber Ag+ | FRO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| February 12, 2014 | K130040 | MEPITEL AG | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| April 5, 2013 | K123892 | MEPILEX TRANSFER AG | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| September 15, 2010 | K100029 | MEPILEX BORDER AG DRESSING | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| July 13, 2007 | K071354 | MEPILEX AG DRESSING | FRO | Substantially Equivalent | Monlycke Health Care | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Dressing, Wound, Occlusive
- All makers of Tape And Bandage, Adhesive
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Dressing, Wound, Hydrophilic
Updated July 1, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.