Cyrex Limited
⚠️ Moderate Risk
FEI: 3008023386 • Herfordshire • UNITED KINGDOM
FEI Number
3008023386
Location
Herfordshire
Country
UNITED KINGDOMAddress
M5 The Maltings, Stanstead Abbots, Herfordshire, , United Kingdom
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).
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.
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | New Orleans District Office (NOL-DO) | |
| 1/21/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 237NO PMA | New Orleans District Office (NOL-DO) |
| 9/23/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 9/18/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 3/10/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/9/2014 | 78KPISTIMULATOR, ELECTRICAL FOR INCONTINENCE (NON-IMPLANTABLE) | New Orleans District Office (NOL-DO) | |
| 6/17/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 6/17/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 5/12/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 2/13/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 1/15/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 1/15/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 5/2/2012 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | New Orleans District Office (NOL-DO) | |
| 5/2/2012 | 84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE | New Orleans District Office (NOL-DO) | |
| 5/2/2012 | 84NHINERVE, STIMULATOR, ELECTRICAL, PERCUTANEOUS (PENS) FOR PAIN RELIEF | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cyrex Limited's FDA import refusal history?
Cyrex Limited (FEI: 3008023386) has 21 FDA import refusal record(s) in our database, spanning from 5/2/2012 to 3/16/2016.
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. Cyrex Limited's FEI number is 3008023386.
What types of violations has Cyrex Limited received?
Cyrex Limited 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 Cyrex Limited come from?
All FDA import refusal data for Cyrex Limited 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.