Philips Medizin Systeme Boeblingen Gmbh
⚠️ Moderate Risk
FEI: 3002807167 • Boblingen, Baden-Wurttemberg • GERMANY
FEI Number
3002807167
Location
Boblingen, Baden-Wurttemberg
Country
GERMANYAddress
Hewlett-Packard-Str. 2, , Boblingen, Baden-Wurttemberg, Germany
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
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 2/16/2023 | 75JQPCALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE | Division of Southeast Imports (DSEI) | |
| 10/24/2005 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 11/21/2003 | 74JOOTRANSDUCER, HEART SOUND | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/21/2003 | 85KXNMONITOR, CARDIAC, FETAL | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/8/2003 | 74DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Philips Medizin Systeme Boeblingen Gmbh's FDA import refusal history?
Philips Medizin Systeme Boeblingen Gmbh (FEI: 3002807167) has 5 FDA import refusal record(s) in our database, spanning from 10/8/2003 to 2/16/2023.
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. Philips Medizin Systeme Boeblingen Gmbh's FEI number is 3002807167.
What types of violations has Philips Medizin Systeme Boeblingen Gmbh received?
Philips Medizin Systeme Boeblingen Gmbh 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 Philips Medizin Systeme Boeblingen Gmbh come from?
All FDA import refusal data for Philips Medizin Systeme Boeblingen Gmbh 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.