Data / Medical devices / Taiwan / Diva Laboratories, Ltd.
Diva Laboratories, Ltd.: FDA-registered device maker in New Taipei City, Taipei-District, 235, Taiwan, 2 510(k) clearances
Diva Laboratories, Ltd. is registered with the FDA (registration 3007817002) in New Taipei City, Taipei-District, 235, Taiwan. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 16, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007817002
- Address
- 9F. No.351, Sec.2 Zhongshan Road Zhonghe Dist., New Taipei City, Taipei-District, 235, Taiwan, 235
- Owner or operator
- DIVA Laboratories, Ltd. (10050307)
- Roles
- Manufacturer
- First device listed
- December 3, 2024
- Registered through
- 2026
- Brand names listed
- GUP2103CMI, Medical Display, ZSP2105CMI with QUBYX PerfectLum
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Display, Diagnostic Radiology | PGY | 2 | Manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | 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 16, 2020 | K191705 | OptikView GUP2103CMI | PGY | Substantially Equivalent | The Linden Group Corp | accessdata.fda.gov |
| February 25, 2016 | K160328 | DIVA ZSP2105CMI with QUBYX PerfectLum bundle | PGY | Substantially Equivalent | The Linden Group Corp | accessdata.fda.gov |
Compare with other makers
- All makers of System, Digital Image Communications, Radiological
- All makers of Display, Diagnostic Radiology
Updated March 16, 2020. 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.