Data / Medical devices / Mauritius / Natec Medical Ltd

Natec Medical Ltd: FDA-registered device maker in Moka, Mauritius, 12 510(k) clearances

Name: Natec Medical Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Natec Medical Ltd is registered with the FDA (registration 3004415014) in Moka, Mauritius. It lists 4 device types. The FDA files 12 510(k) clearances under its listings, the newest dated December 18, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004415014
Address: Ava Technopark, Med tech road, Cote DOr Technopole, Minissy, Cote DOr, Moka, Mauritius, 80829
Owner or operator: NATEC MEDICAL LTD (9060577)
Roles: Contract manufacturer, Manufacturer
First device listed: March 1, 2013
Registered through: 2026
Brand names listed: Amethyst HP PTA OTW 035, Amethyst HP PTA OTW 035" Catheter, EBONY 14" PTA catheters, EBONY 14'' PTA Catheters, Ebony 014" PTA OTW Catheter, Ebony 018" PTA OTW Catheter, Victory 014" & 018" PTA OTW Catheter, Ebony 014" PTA Rx Catheter, Ebony HP PTA OTW 035, Ebony HP PTA OTW 035" Catheter, Victory HP PTA OTW 035" Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Contract manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, Percutaneous	LOX	2	Contract manufacturer, Manufacturer	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
December 18, 2025	K251915	Amethyst HP PTA OTW 0.035 Catheter	LIT	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
December 18, 2024	K241040	Amethyst HP PTA OTW 0.035 Catheter	LIT	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
June 29, 2022	K220410	Ebony HP PTA OTW 0.035 Catheter	LIT	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
July 9, 2021	K210012	Tamarin Blue PTCA RX Dilatation Catheter	LOX	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
September 3, 2015	K152230	Ebony PTA .014 RX Pheripheral Dilatation Catheter	LIT	Substantially Equivalent	Natec Medical	accessdata.fda.gov
June 28, 2015	K141933	FILAO NC RX PTCA DILATATION CATHETER	LOX	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
June 4, 2015	K143041	Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter	LIT	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
March 30, 2015	K143036	Ebony PTA 0.035 Peripheral Dilatation Catheter	LIT	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
February 3, 2015	K142459	Ebony PTA 0.014 RX Peripheral Dilatation Catheter	LIT	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
November 2, 2012	K112735	TAMARIN BLUE PTCA RX DILATATION CATHETER	LOX	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
December 9, 2011	K112513	EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER	LIT	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov
February 23, 2011	K103354	EBONY PTA .035 PERIPHERAL DILATATION CATHETER	LIT	Substantially Equivalent	Natec Medical , Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 18, 2025. 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.