Data / Medical devices / Belgium / Kci Polymedics BV
Kci Polymedics BV: FDA-registered device maker in PEER Limburg, Belgium, 1 510(k) clearance
Kci Polymedics BV is registered with the FDA (registration 3003775292) in PEER Limburg, Belgium. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 27, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003775292
- Address
- 1031, Ambachtslaan, PEER Limburg, Belgium, 3990
- Owner or operator
- Solventum US LLC (10091183)
- Roles
- Manufacturer
- First device listed
- October 29, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | 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 |
|---|---|---|---|---|---|---|
| October 27, 2021 | K203316 | V.A.C.ULTA Negative Pressure Wound Therapy System | OMP | Substantially Equivalent | Kci, A Part of 3M Health Care Business Group | accessdata.fda.gov |
Compare with other makers
Updated October 27, 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.