Data / Medical devices / Netherlands / Arjohuntleigh Logistics
Arjohuntleigh Logistics: FDA-registered device maker in Eindhoven Noord-Brabant, Netherlands, 1 510(k) clearance
Arjohuntleigh Logistics is registered with the FDA (registration 3007518069) in Eindhoven Noord-Brabant, Netherlands. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007518069
- Address
- High Tech Campus 21, Eindhoven Noord-Brabant, Netherlands, NL-5656 AE
- Owner or operator
- ArjoHuntleigh AB (10036598)
- Roles
- Exporter to the US
- First device listed
- May 17, 2011
- Registered through
- 2026
- Brand names listed
- SARA PLUS (FOREIGN EXPORTER ONLY), Various Arjo slings, WoundExpress Pump, WoundExpress Garment
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Exporter to the US | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | 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 |
|---|---|---|---|---|---|---|
| September 3, 2021 | K211200 | WoundExpress | JOW | Substantially Equivalent | Huntleigh Healthcare , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 3, 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.