Data / Medical devices / South Africa / Disa Medinotec (pty) Ltd
Disa Medinotec (pty) Ltd: FDA-registered device maker in Northriding, Johannesburg Gauteng, South Africa, 2 510(k) clearances
Disa Medinotec (pty) Ltd is registered with the FDA (registration 3021230784) in Northriding, Johannesburg Gauteng, South Africa. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021230784
- Address
- Stand 171, Northlands Business Park, Bush Telegraph Street, Northriding, Johannesburg Gauteng, South Africa, 2169
- Owner or operator
- DISA Medinotec (Pty) Ltd (10083849)
- Roles
- Manufacturer
- First device listed
- December 23, 2021
- Registered through
- 2026
- Brand names listed
- OutFlo Aortic Valve Valvuloplasty Perfusion Dilatation Catheter, Trachealator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Balloon Aortic Valvuloplasty | OZT | 2 | Manufacturer | accessdata.fda.gov |
| Bronchoscope Accessory | KTI | 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 |
|---|---|---|---|---|---|---|
| March 11, 2025 | K241562 | OutFlo Aortic Valve Dilatation Balloon Catheter | OZT | Substantially Equivalent | Disa Medinotec | accessdata.fda.gov |
| November 24, 2021 | K211894 | Trachealator | KTI | Substantially Equivalent | Disa Medinotec | accessdata.fda.gov |
Compare with other makers
Updated March 11, 2025. 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.