MICROTEK MEDICAL MALTA LIMITED

FDA Device Registration & Listing · Mosta, MT · Registration 3006581049

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006581049
FEI Number
3006581049
Entity Name
MICROTEK MEDICAL MALTA LIMITED
City/State/Country
Mosta, MT
Establishment Address
SORBONNE CENTRE F20, MOSTA TECHNOPARK, Mosta MST 3000, MT
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Medline Industries, LP (Owner Number: 1417592)
Owner / Operator Contact Address
Three Lakes Drive, Northfield, IL 60093, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Disposable Equipment Covers Probe Cover Gel MTP Extraction Bag

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MMP Cover, Barrier, Protective General, Plastic Surgery Class 2 878.4370 2024-10-30
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-10-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-10-30

Official Correspondent

Stephanie Augsburg

US Agent Details

Rosanna Lee Business: Simcon International LLC Email: rlee@simconintl.com Phone: (847) 9492290

Related Public Records

Same Entity

Medline Industries, LP
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007128716 Medline Industries, LP Norristown, PA, US
3036706541 EXCELSIOR MEDICAL LLC Tinton Falls, NJ, US
3016073670 Medline Logistics Japan G.K. Nishihocho, Aisai-shi Aichi, JP
3010389834 Microtek Medical B.V. Varsseveld VARSSEVELD Gelderland, NL
2125337 Medline Industries, LP North Mankato, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K882805 Coopervision-Cilco CILCO VILLASENOR PACHYMETER 1988-08-12
K791040 Shimadzu Corp. SECTOR SCANNER, SDU-100, COMPUTERIZED 1979-10-04
K162372 Qt Ultrasound, LLC QT Ultrasound Breast Scanner-1 2017-06-06
K930964 Acuson Corp. ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) 1994-10-26
K052355 U-Systems, Inc. AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS 2005-09-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0003-2011 Verathon, Inc. 2
BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011 Verathon, Inc. 2
AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011 Verathon, Inc. 2
BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014 SonoSite, Inc. 2
P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006581049. Last updated year: 2026. Please use registration number 3006581049 when referencing this establishment in official correspondence.
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