Data / Medical devices / Malta / Microtek Medical Malta Limited
Microtek Medical Malta Limited: FDA-registered device maker in Mosta, Malta, 1 510(k) clearance
Microtek Medical Malta Limited is registered with the FDA (registration 3006581049) in Mosta, Malta. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 10, 1980. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006581049
- Address
- Sorbonne Centre F20 Mosta Technopark, Mosta, Malta, MST 3000
- Owner or operator
- Medline Industries, LP (1417592)
- Roles
- Contract manufacturer, Repackager or relabeler
- First device listed
- August 25, 2017
- Registered through
- 2026
- Brand names listed
- AKTORmed, Convertors, Disposable Equipment Covers, Eclipse Surgical Drape, Lingeman, MTP Extraction Bag, Medline Band Bag, Medline Dome Bag and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Barrier, Protective | MMP | 2 | Contract manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 10, 1980 | K802146 | AQUASONIC 100 ULTRASOUND TRANS. GEL, | IYO | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Drape, Surgical, Exempt
- All makers of Cover, Barrier, Protective
- All makers of Laparoscope, General & Plastic Surgery
Updated October 10, 1980. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.