Data / Medical devices / Taiwan / Crystalvue Medical Corporation
Crystalvue Medical Corporation: FDA-registered device maker in Taoyuan Dist.,, Taiwan, 3 510(k) clearances
Crystalvue Medical Corporation is registered with the FDA (registration 3010000450) in Taoyuan Dist.,, Taiwan. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 13, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010000450
- Address
- No.116, Ln.956, Zhongshan Rd., Taoyuan Dist.,, Taiwan, 33072
- Owner or operator
- CRYSTALVUE MEDICAL CORPORATION (10045401)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 12, 2013
- Registered through
- 2026
- Brand names listed
- CADENCE 100, EZER EFC-2600, EZER ETN-1800, HALO, Milli Vaginal Dilator, NFC-600, NFC-700, Polaris and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dilator, Vaginal | HDX | 2 | Contract manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Ophthalmoscope, Ac-Powered | HLI | 2 | Contract manufacturer | accessdata.fda.gov |
| Tomography, Optical Coherence | OBO | 2 | Contract manufacturer | accessdata.fda.gov |
| Tonometer, Ac-Powered | HKX | 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 |
|---|---|---|---|---|---|---|
| April 13, 2021 | K210197 | NFC-600 Automated Portable Retinal Camera | HKI | Substantially Equivalent | Crystalvue Medical Corporation | accessdata.fda.gov |
| January 2, 2019 | K182199 | NFC-700 non-mydriatic auto fundus camera | HKI | Substantially Equivalent | Crystalvue Medical Corporation | accessdata.fda.gov |
| December 14, 2018 | K180820 | Tono Vue Non-Contact Tonometer | HKX | Substantially Equivalent | Crystalvue Medical Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Camera, Ophthalmic, Ac-Powered
- All makers of Dilator, Vaginal
- All makers of Ophthalmoscope, Ac-Powered
- All makers of Tomography, Optical Coherence
- All makers of Medical Device Data System
- All makers of Tonometer, Ac-Powered
Updated April 13, 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.