Maquet Critical Care AB
⚠️ Moderate Risk
FEI: 3002808128 • Solna, Stockholms Lan • SWEDEN
FEI Number
3002808128
Location
Solna, Stockholms Lan
Country
SWEDENAddress
Rontgenvagen 2, , Solna, Stockholms Lan, Sweden
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2015 | 73BZOSET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) | 508NO 510(K) | San Juan District Office (SJN-DO) |
| 8/22/2008 | 74DPTPROBE, BLOOD-FLOW, EXTRAVASCULAR | New Orleans District Office (NOL-DO) | |
| 8/22/2008 | 74DTMFILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE | New Orleans District Office (NOL-DO) | |
| 9/22/2005 | 61CCP99ANTI-ANEMIC, N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/22/2005 | 61CCP99ANTI-ANEMIC, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Maquet Critical Care AB's FDA import refusal history?
Maquet Critical Care AB (FEI: 3002808128) has 5 FDA import refusal record(s) in our database, spanning from 9/22/2005 to 7/21/2015.
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. Maquet Critical Care AB's FEI number is 3002808128.
What types of violations has Maquet Critical Care AB received?
Maquet Critical Care AB 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 Maquet Critical Care AB come from?
All FDA import refusal data for Maquet Critical Care AB 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.