FDA Registration
Active
🇹🇼 Taiwan
CRYSTALVUE MEDICAL CORPORATION
Reg #: 3010000450
·
FEI: 3010000450
·
Expires 2026
Products
6
Proprietary Names
17
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- CRYSTALVUE MEDICAL CORPORATION
- Registration Number
- 3010000450
- FEI Number
- 3010000450
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.116, Ln.956, Zhongshan Rd.,
- City
- Taoyuan Dist.,
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K210197
Owner / Operator
- Firm Name
- CRYSTALVUE MEDICAL CORPORATION
- Operator Number
- 10045401
- Address
- No.116, Ln.956, Zhongshan Rd.,
- City
- Taoyuan Dist.,
- State
- TW-TAO
- Postal Code
- 330
- Country
- TW
- Correspondent
- Beth Wang
US Agent
- Business Name
- Harvest & Victory Consulting Corp.(USA)
- Contact Name
- Jennifer Reich
- Address
- 2904 N Boldt Dr
- City
- Flagstaff
- State
- AZ
- ZIP
- 86001
- Country
- US
- [email protected]
- Phone
- 928 8638140
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2023-01-04 |
| Ophthalmoscope, Ac-Powered | HLI | Class 2 | Ophthalmic | No | 2023-01-04 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2023-01-04 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2024-03-30 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2019-01-17 |
| Dilator, Vaginal | HDX | Class 2 | Obstetrics/Gynecology | No | 2022-02-08 |
Proprietary Names
Solix
RTVue XR
RTVue XR OCT
RTVue XR OCT Avanti
HALO
NFC-600
VitaziView
NFC-700
CADENCE 100
Polaris
EZER EFC-2600
iScan
TonoVue
EZER ETN-1800
iFusion
Milli Vaginal Dilator
iVue
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device