Data / Medical devices / United Kingdom / Molnlycke Health Care
Molnlycke Health Care: FDA-registered device maker in Oldham, United Kingdom, 1 510(k) clearance
Molnlycke Health Care is registered with the FDA (registration 8020673) in Oldham, United Kingdom. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 25, 2016. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8020673
- FEI number
- 2819
- Address
- TUBITON HOUSE Medlock Street, Oldham, United Kingdom, OL1 3HS
- Owner or operator
- MOLNLYCKE HEALTH CARE US LLC (8030877)
- Roles
- Manufacturer
- First device listed
- December 21, 2005
- Registered through
- 2026
- Brand names listed
- ALLDRESS, Dermafit, Elset, Exufiber, Exufiber Ag+, MEPORE, MESALT, Melgisorb Plus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 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 |
|---|---|---|---|---|---|---|
| August 25, 2016 | K160379 | Exufiber Ag+ | FRO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrophilic
- All makers of Bandage, Elastic
Updated August 25, 2016. 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.