Natus Medical Denmark ApS
⚠️ Moderate Risk
FEI: 3002807554 • Taastrup, Hovedstaden • DENMARK
FEI Number
3002807554
Location
Taastrup, Hovedstaden
Country
DENMARKAddress
Horskatten 9, , Taastrup, Hovedstaden, Denmark
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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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.
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/16/2009 | 77EWOAUDIOMETER | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 9/16/2009 | 77EWOAUDIOMETER | Chicago District Office (CHI-DO) | |
| 9/10/2009 | 77EWOAUDIOMETER | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 6/24/2009 | 77EWOAUDIOMETER | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 12/11/2008 | 77EWOAUDIOMETER | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 12/11/2008 | 77EWOAUDIOMETER | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
| 12/2/2008 | 77EWOAUDIOMETER | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 11/5/2008 | 77EWOAUDIOMETER | 2780DEVICEGMPS | Minneapolis District Office (MIN-DO) |
| 9/26/2008 | 77EWOAUDIOMETER | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 7/6/2005 | 77ESDHEARING-AID, AIR-CONDUCTION | 508NO 510(K) | Chicago District Office (CHI-DO) |
| 4/28/2005 | 77ESDHEARING-AID, AIR-CONDUCTION | 508NO 510(K) | Chicago District Office (CHI-DO) |
| 8/19/2002 | 77ETYTESTER, AUDITORY IMPEDANCE | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
| 8/7/2002 | 84GWNNYSTAGMOGRAPH | 126FAILS STD | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Natus Medical Denmark ApS's FDA import refusal history?
Natus Medical Denmark ApS (FEI: 3002807554) has 13 FDA import refusal record(s) in our database, spanning from 8/7/2002 to 9/16/2009.
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. Natus Medical Denmark ApS's FEI number is 3002807554.
What types of violations has Natus Medical Denmark ApS received?
Natus Medical Denmark ApS has been cited for 5 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 Natus Medical Denmark ApS come from?
All FDA import refusal data for Natus Medical Denmark ApS 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.