Sonoscape Company, Ltd.
⚠️ Moderate Risk
FEI: 3004705634 • Shenzhen, Guangdong • CHINA
FEI Number
3004705634
Location
Shenzhen, Guangdong
Country
CHINAAddress
Yizhe Building F/4, , Shenzhen, Guangdong, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2013 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Los Angeles District Office (LOS-DO) | |
| 8/14/2013 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Los Angeles District Office (LOS-DO) | |
| 8/14/2013 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | Los Angeles District Office (LOS-DO) | |
| 2/7/2005 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | 341REGISTERED | Chicago District Office (CHI-DO) |
| 2/7/2005 | 90IYOSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC | 341REGISTERED | Chicago District Office (CHI-DO) |
| 2/7/2005 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | 341REGISTERED | Chicago District Office (CHI-DO) |
| 12/9/2004 | 85LQTDOPPLER ULTRASOUND FOR FETAL EVALUATION | Division of Southeast Imports (DSEI) | |
| 12/9/2004 | 85LQTDOPPLER ULTRASOUND FOR FETAL EVALUATION | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Sonoscape Company, Ltd.'s FDA import refusal history?
Sonoscape Company, Ltd. (FEI: 3004705634) has 8 FDA import refusal record(s) in our database, spanning from 12/9/2004 to 8/14/2013.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Sonoscape Company, Ltd.'s FEI number is 3004705634.
What types of violations has Sonoscape Company, Ltd. received?
Sonoscape Company, Ltd. has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Sonoscape Company, Ltd. come from?
All FDA import refusal data for Sonoscape Company, Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.