NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)
⚠️ Moderate Risk
FEI: 3002809369 • Oakville, Ontario • CANADA
FEI Number
3002809369
Location
Oakville, Ontario
Country
CANADAAddress
2568 Bristol Cir, , Oakville, Ontario, Canada
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
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).
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).
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.
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2022 | 86HKICAMERA, OPHTHALMIC, AC-POWERED | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 4/6/2020 | 84GWQELECTROENCEPHALOGRAPH | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 6/6/2014 | 84GXZELECTRODE, NEEDLE | New Orleans District Office (NOL-DO) | |
| 1/31/2013 | 84GWESTIMULATOR, PHOTIC, EVOKED RESPONSE | New Orleans District Office (NOL-DO) | |
| 12/10/2010 | 78FLAMONITOR, TEMPERATURE, DIALYSIS | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 5/18/2006 | 89LPQSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP | 476NO REGISTR | New York District Office (NYK-DO) |
| 8/23/2004 | 84GWQELECTROENCEPHALOGRAPH | 341REGISTERED | Detroit District Office (DET-DO) |
| 7/7/2004 | 80LDQDEVICE, GENERAL MEDICAL | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)'s FDA import refusal history?
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) (FEI: 3002809369) has 8 FDA import refusal record(s) in our database, spanning from 7/7/2004 to 7/11/2022.
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 INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)'s FEI number is 3002809369.
What types of violations has NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) received?
NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) 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 INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) come from?
All FDA import refusal data for NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) 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.