PT. MEDISAFE TECHNOLOGIES
⚠️ High Risk
FEI: 3002955419 • Deli Serdang, Sumatera utara • INDONESIA
FEI Number
3002955419
Location
Deli Serdang, Sumatera utara
Country
INDONESIAAddress
Kuis Gg. Tambak Rejo / Psr Ix, Desa/Kelurahan Buntu Badimbar, Kec.Tanjung Morawa, Jln. Batang Kuis 151, Deli Serdang, Sumatera utara, Indonesia
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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.
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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 |
|---|---|---|---|
| 7/17/2025 | 80KGOSURGEON'S GLOVES | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 7/17/2025 | 80KGOSURGEON'S GLOVES | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 7/17/2025 | 80KGOSURGEON'S GLOVES | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 7/17/2025 | 80KGOSURGEON'S GLOVES | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 3/1/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Chicago District Office (CHI-DO) | |
| 7/30/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 7/30/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 126FAILS STD | Los Angeles District Office (LOS-DO) |
| 8/31/2005 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 8/31/2005 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 6/8/2005 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New England District Office (NWE-DO) |
Frequently Asked Questions
What is PT. MEDISAFE TECHNOLOGIES's FDA import refusal history?
PT. MEDISAFE TECHNOLOGIES (FEI: 3002955419) has 10 FDA import refusal record(s) in our database, spanning from 6/8/2005 to 7/17/2025.
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. PT. MEDISAFE TECHNOLOGIES's FEI number is 3002955419.
What types of violations has PT. MEDISAFE TECHNOLOGIES received?
PT. MEDISAFE TECHNOLOGIES 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 PT. MEDISAFE TECHNOLOGIES come from?
All FDA import refusal data for PT. MEDISAFE TECHNOLOGIES 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.