Teleflex Medical de Mexico, S. de R.L. de C.V.
⚠️ High Risk
FEI: 3004365956 • Nuevo Laredo • MEXICO
FEI Number
3004365956
Location
Nuevo Laredo
Country
MEXICOAddress
Ave. Industrias 5954, Parque Industrial Finsa, Nuevo Laredo, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2025 | 78KNYACCESSORIES, CATHETER, G-U | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 5/1/2020 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 5/1/2020 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 5/1/2020 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 5/1/2020 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 5/1/2020 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 5/1/2020 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 5/1/2020 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 5/1/2020 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 9/16/2019 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | Division of Southwest Imports (DSWI) | |
| 6/13/2017 | 73CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY | Division of Southwest Imports (DSWI) | |
| 12/12/2014 | 73BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/6/2014 | 78FGFCATHETER, URETERAL DISPOSABLE (X-RAY) | New England District Office (NWE-DO) | |
| 3/6/2014 | 78FGFCATHETER, URETERAL DISPOSABLE (X-RAY) | New England District Office (NWE-DO) | |
| 3/6/2014 | 73BYGMASK, OXYGEN | New England District Office (NWE-DO) | |
| 10/12/2011 | 73BWBFORCEPS, TUBE INTRODUCTION | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/13/2010 | 79GASSUTURE, NONABSORBABLE, SYNTHETIC, POLYESTER | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/1/2006 | 80LDQDEVICE, GENERAL MEDICAL | 333LACKS FIRM | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Teleflex Medical de Mexico, S. de R.L. de C.V.'s FDA import refusal history?
Teleflex Medical de Mexico, S. de R.L. de C.V. (FEI: 3004365956) has 18 FDA import refusal record(s) in our database, spanning from 5/1/2006 to 12/23/2025.
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. Teleflex Medical de Mexico, S. de R.L. de C.V.'s FEI number is 3004365956.
What types of violations has Teleflex Medical de Mexico, S. de R.L. de C.V. received?
Teleflex Medical de Mexico, S. de R.L. de C.V. has been cited for 7 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 Teleflex Medical de Mexico, S. de R.L. de C.V. come from?
All FDA import refusal data for Teleflex Medical de Mexico, S. de R.L. de C.V. 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.