Elmed Instruments Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3000183921 • Sialkot, Punjab • PAKISTAN
FEI Number
3000183921
Location
Sialkot, Punjab
Country
PAKISTANAddress
Roras Road Nowl Chowk, , Sialkot, Punjab, Pakistan
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
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).
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 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 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/21/2020 | 79GDZHANDLE, SCALPEL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 79FZSCURETTE, SURGICAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 79HTDFORCEPS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/21/2020 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 84HAOINSTRUMENT, SURGICAL, NON-POWERED | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 76EMMCHISEL, OSTEOTOME, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 79GFIOSTEOTOME, MANUAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/27/2019 | 78KPISTIMULATOR, ELECTRICAL FOR INCONTINENCE (NON-IMPLANTABLE) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 79GDZHANDLE, SCALPEL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 79FZSCURETTE, SURGICAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 79HTDFORCEPS | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 76EILGAUGE, DEPTH, INSTRUMENT, DENTAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 11/2/2009 | 80LDQDEVICE, GENERAL MEDICAL | 508NO 510(K) | Florida District Office (FLA-DO) |
| 5/21/2008 | 80LDQDEVICE, GENERAL MEDICAL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Elmed Instruments Pvt. Ltd.'s FDA import refusal history?
Elmed Instruments Pvt. Ltd. (FEI: 3000183921) has 67 FDA import refusal record(s) in our database, spanning from 5/21/2008 to 12/21/2020.
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. Elmed Instruments Pvt. Ltd.'s FEI number is 3000183921.
What types of violations has Elmed Instruments Pvt. Ltd. received?
Elmed Instruments Pvt. Ltd. has been cited for 4 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 Elmed Instruments Pvt. Ltd. come from?
All FDA import refusal data for Elmed Instruments Pvt. Ltd. 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.