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
Phone
928 8638140

Products

Device Name Product Code
Tomography, Optical Coherence OBO
Ophthalmoscope, Ac-Powered HLI
Camera, Ophthalmic, Ac-Powered HKI
Medical Device Data System OUG
Tonometer, Ac-Powered HKX
Dilator, Vaginal HDX

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