Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006550224

FEI Number

3006550224

Entity Name

NATEC MEDICAL LTD (Maurister)

City/State/Country

BAMBOUS Riviere du Rempart, MU

Establishment Address

MEDIA BUILDING-GEOFFREY ROAD, BAMBOUS Riviere du Rempart 90104, MU

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

NATEC MEDICAL LTD (Owner Number: 9060577)

Owner / Operator Contact Address

Ava Technopark, Med tech road, Cote DOr Technopole, Minissy, Cote DOr, Moka, MU-NOTA 80829, MU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EBONY 14" PTA catheters USE014 Ebony 014" PTA Rx Catheter USE 014/018otw Ebony PTA 014/018 OTW Ebony 014" PTA OTW Catheter, Ebony 018" PTA OTW Catheter, Victory 014" & 018" PTA OTW Catheter Ebony PTA 035OTW USE 035 OTW Tamarin Blue PTCA Catheters USE014 RX Ebony PTA014RX Ebony PTA 035OTW USE 035 Ebony HP PTA OTW 035 Ebony HP PTA OTW 035" Catheter, Victory HP PTA OTW 035" Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-12-18
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2024-12-18
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2016-01-14
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-06-19
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2013-03-01
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2013-03-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-02-12
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2015-04-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2022-08-01

Official Correspondent

VINCENT LAGARDE

US Agent Details

Semih Oktay H. Semih Oktay Business: CardioMed Device Consultants, LLC Email: Soktay@Cardiomedllc.com Phone: (410) 6742060

Related Public Records

Same Entity

NATEC MEDICAL LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004415014	NATEC MEDICAL LTD	Moka, MU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171251	Creagh Medical	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2017-09-08
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K252512	ABBOTT MEDICAL	Armada 14 NC PTA Catheter	2026-02-13
K142654	Covidien, LLC	Fortrex 0.035 OTW PTA Balloon Catheter	2014-10-28
K202800	Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)	Pacific Plus PTA Catheter	2020-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006550224. Last updated year: 2026. Please use registration number 3006550224 when referencing this establishment in official correspondence.