Hako Med Gmbh
⚠️ Moderate Risk
FEI: 3001190829 • Karlsruhe, Baden-Wurttemberg • GERMANY
FEI Number
3001190829
Location
Karlsruhe, Baden-Wurttemberg
Country
GERMANYAddress
Eisenbahnstr. 36, , Karlsruhe, 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
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.
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2002 | 89IPFSTIMULATOR, MUSCLE, POWERED | 126FAILS STD | San Francisco District Office (SAN-DO) |
| 4/5/2002 | 89IPFSTIMULATOR, MUSCLE, POWERED | San Francisco District Office (SAN-DO) | |
| 4/5/2002 | 89IPFSTIMULATOR, MUSCLE, POWERED | San Francisco District Office (SAN-DO) | |
| 4/5/2002 | 89IPFSTIMULATOR, MUSCLE, POWERED | 126FAILS STD | San Francisco District Office (SAN-DO) |
| 4/5/2002 | 89IPFSTIMULATOR, MUSCLE, POWERED | 126FAILS STD | San Francisco District Office (SAN-DO) |
| 4/5/2002 | 89IPFSTIMULATOR, MUSCLE, POWERED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Hako Med Gmbh's FDA import refusal history?
Hako Med Gmbh (FEI: 3001190829) has 6 FDA import refusal record(s) in our database, spanning from 4/5/2002 to 5/22/2002.
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. Hako Med Gmbh's FEI number is 3001190829.
What types of violations has Hako Med Gmbh received?
Hako Med Gmbh has been cited for 3 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 Hako Med Gmbh come from?
All FDA import refusal data for Hako Med 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.