Data / Medical devices / South Korea / Meditime Co., Ltd
Meditime Co., Ltd: FDA-registered device maker in Won Ju Gangwon, South Korea, 1 510(k) clearance
Meditime Co., Ltd is registered with the FDA (registration 3016244792) in Won Ju Gangwon, South Korea. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016244792
- Address
- Medical Complex #605, 200 Gieopdosi Ro Jieong myeon, Won Ju Gangwon, South Korea, 26354
- Owner or operator
- Meditime Co., Ltd (10062079)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 16, 2019
- Registered through
- 2026
- Brand names listed
- VIOLA / Les Encres
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Manufacturer, Repackager or relabeler | 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 15, 2019 | K190264 | Viola | NEW | Substantially Equivalent | Meditime Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 15, 2019. 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.