Shenzhen Oceanus Medical Device Co., Ltd.
⚠️ Moderate Risk
FEI: 3013431847 • Shenzhen, Guangdong • CHINA
FEI Number
3013431847
Location
Shenzhen, Guangdong
Country
CHINAAddress
Nanshan District Rm 601, Bldg B, Thunis Information Port; High Tech North Area, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is Shenzhen Oceanus Medical Device Co., Ltd.'s FDA import refusal history?
Shenzhen Oceanus Medical Device Co., Ltd. (FEI: 3013431847) has 1 FDA import refusal record(s) in our database, spanning from 7/7/2017 to 7/7/2017.
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. Shenzhen Oceanus Medical Device Co., Ltd.'s FEI number is 3013431847.
What types of violations has Shenzhen Oceanus Medical Device Co., Ltd. received?
Shenzhen Oceanus Medical Device Co., 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 Shenzhen Oceanus Medical Device Co., Ltd. come from?
All FDA import refusal data for Shenzhen Oceanus Medical Device Co., 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.