Data / Medical devices / Rwanda / TKMD Rwanda Ltd
TKMD Rwanda Ltd: FDA-registered device maker in Rwamagana, lburasirazuba Eastern Province, Rwanda, 2 510(k) clearances
TKMD Rwanda Ltd is registered with the FDA (registration 3035455509) in Rwamagana, lburasirazuba Eastern Province, Rwanda. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035455509
- Address
- Mwulire, Rwamagana, lburasirazuba Eastern Province, Rwanda, 999051
- Owner or operator
- TKMD RWANDA Ltd (10092465)
- Roles
- Manufacturer
- First device listed
- January 10, 2025
- Registered through
- 2026
- Brand names listed
- Auto Disable Syringe, Oral/Enteral Syringe with ENFit connector
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 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 |
|---|---|---|---|---|---|---|
| August 17, 2023 | K222772 | Oral/Enteral Syringe with ENFit connector | PNR | Substantially Equivalent | Anhui Tiankang Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 24, 2021 | K210464 | Auto Disable Syringe | FMF | Substantially Equivalent | Anhui Tiankang Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 17, 2023. 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.