Scandinavian Health Ltd.
✅ Low Risk
FEI: 3004483565 • Taoyuan City • TAIWAN
FEI Number
3004483565
Location
Taoyuan City
Country
TAIWANAddress
NO. 136 KUO SHENG 2ND STREET, , Taoyuan City, , Taiwan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/23/2017 | 80KZHINTRODUCER, SYRINGE NEEDLE | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Scandinavian Health Ltd.'s FDA import refusal history?
Scandinavian Health Ltd. (FEI: 3004483565) has 1 FDA import refusal record(s) in our database, spanning from 1/23/2017 to 1/23/2017.
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. Scandinavian Health Ltd.'s FEI number is 3004483565.
What types of violations has Scandinavian Health Ltd. received?
Scandinavian Health Ltd. has been cited for 1 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 Scandinavian Health Ltd. come from?
All FDA import refusal data for Scandinavian Health 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.