Data / Medical devices / Belgium / Deufol Waremme Operations
Deufol Waremme Operations: FDA-registered device maker in Waremme Liege, Belgium, 10 510(k) clearances
Deufol Waremme Operations is registered with the FDA (registration 3030172764) in Waremme Liege, Belgium. It lists 11 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 1, 2021. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030172764
- Address
- Rue du Parc Industriel 29, Waremme Liege, Belgium, 4300
- Owner or operator
- Deufol Waremme Operations (10089314)
- Roles
- Exporter to the US
- First device listed
- December 15, 2023
- Registered through
- 2026
- Brand names listed
- Alldress, Avance Solo, Avance Solo NPWT System, Barrier Medical Face Mask, Barrier Nurse's Cap, Barrier Surgical Cap, Barrier Surgical Hood, Biogel PI and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Elastic | FQM | 1 | Exporter to the US | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Exporter to the US | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Exporter to the US | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Exporter to the US | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Exporter to the US | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Exporter to the US | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Exporter to the US | 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 |
| August 31, 2015 | K150146 | Biogel PI Micro Indicator Underglove | KGO | Substantially Equivalent | Molnlycke Health Care Us, LLC | accessdata.fda.gov |
| April 5, 2013 | K123892 | MEPILEX TRANSFER AG | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| March 14, 2011 | K110458 | SILVER ANTIMICROBIAL WOUND GEL | FRO | Substantially Equivalent | Advanced Medical Solutions Limited | accessdata.fda.gov |
| September 15, 2010 | K100029 | MEPILEX BORDER AG DRESSING | FRO | Substantially Equivalent | Molnlycke Health Care | accessdata.fda.gov |
| February 26, 2009 | K090453 | SILVER ALGINATE 11 WOUND DRESSING | FRO | Substantially Equivalent | Advanced Medical Solutions Limited | accessdata.fda.gov |
| July 13, 2007 | K070581 | SILVER ALGINATE II WOUND DRESSING | FRO | Substantially Equivalent | Advanced Medical Solutions Limited | accessdata.fda.gov |
| March 16, 2005 | K050184 | BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE | KGO | Substantially Equivalent | Regent Medical Americas, LLC | accessdata.fda.gov |
| April 29, 1991 | K910557 | BARRIER* EXTRA PROTECTION PLUS FACE MASK | FXX | Substantially Equivalent | Johnson & Johnson Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Surgeon'S Gloves
- All makers of Mask, Surgical
- All makers of Dressing, Wound, Drug
- All makers of Protector, Skin Pressure
- All makers of Dressing, Wound, Occlusive
- 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.