Dameca As
⚠️ Moderate Risk
FEI: 3002899159 • R?dovre • DENMARK
FEI Number
3002899159
Location
R?dovre
Country
DENMARKAddress
Islevdalvej 211, , R?dovre, , 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
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).
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/13/2006 | 73BSZGAS MACHINE, ANESTHESIA | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/22/2005 | 73BSZGAS MACHINE, ANESTHESIA | 508NO 510(K) | Florida District Office (FLA-DO) |
| 4/11/2005 | 73JFEVALVE, SWITCHING (PLOSS) | Division of Southeast Imports (DSEI) | |
| 4/11/2005 | 73BSZGAS MACHINE, ANESTHESIA | Division of Southeast Imports (DSEI) | |
| 9/9/2003 | 73KGACYLINDER, GAS(EMPTY) | Florida District Office (FLA-DO) | |
| 5/24/2002 | 73BWLAPPARATUS, ELECTRONANESTHESIA | Florida District Office (FLA-DO) | |
| 5/24/2002 | 73BWLAPPARATUS, ELECTRONANESTHESIA | Florida District Office (FLA-DO) | |
| 5/17/2002 | 73BWLAPPARATUS, ELECTRONANESTHESIA | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Dameca As's FDA import refusal history?
Dameca As (FEI: 3002899159) has 8 FDA import refusal record(s) in our database, spanning from 5/17/2002 to 4/13/2006.
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. Dameca As's FEI number is 3002899159.
What types of violations has Dameca As received?
Dameca As 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 Dameca As come from?
All FDA import refusal data for Dameca As 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.