Taiwan FDA registration 53a9982191f51cd3c9f22bd558549c8c
“FUJIFILM SonoSite” PX Ultrasound System
TW: “富士索諾聲” 超音波系統
Taiwan·Risk Class 2·MD·FUJIFILM Sonosite, Inc.·Registered Oct 21, 2021 – Oct 21, 2026ActiveRegistration details
- Analysis ID
- 53a9982191f51cd3c9f22bd558549c8c
- License Form
- Ministry of Health Medical Device Import No. 035003
- Customs Code
- DHA05603500302
Company information
- Manufacturer
- FUJIFILM Sonosite, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- EMERGO TAIWAN LIMITED
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- P Devices for radiology
- Product Type (Level 2)
- P1550 ultrasonic pulsating Doppler imaging system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Oct 21, 2021
- Expiry Date
- Oct 21, 2026
About this record
Access comprehensive regulatory information for “FUJIFILM SonoSite” PX Ultrasound System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 53a9982191f51cd3c9f22bd558549c8c and manufactured by FUJIFILM Sonosite, Inc.. The authorized representative in Taiwan is EMERGO TAIWAN LIMITED.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices