Spacelabs Healthcare Gmbh
⚠️ Moderate Risk
FEI: 3010677741 • Nurnberg, Bayern • GERMANY
FEI Number
3010677741
Location
Nurnberg, Bayern
Country
GERMANYAddress
Sudwest Park 40, , Nurnberg, Bayern, 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
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 |
|---|---|---|---|
| 3/13/2025 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) | |
| 3/13/2025 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) | |
| 3/13/2025 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Spacelabs Healthcare Gmbh's FDA import refusal history?
Spacelabs Healthcare Gmbh (FEI: 3010677741) has 3 FDA import refusal record(s) in our database, spanning from 3/13/2025 to 3/13/2025.
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. Spacelabs Healthcare Gmbh's FEI number is 3010677741.
What types of violations has Spacelabs Healthcare Gmbh received?
Spacelabs Healthcare Gmbh has been cited for 2 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 Spacelabs Healthcare Gmbh come from?
All FDA import refusal data for Spacelabs Healthcare 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.