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Natec Medical , Ltd.

USA · Reduit

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Israel, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 26 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class IV 3

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States26 registration records, 12 510(k), 0 PMA

Brazil4 confirmed, 0 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: NATEC MEDICAL LTD · NATEC MEDICAL LTD (Maurister) · NATEC MEDICAL LTD.

FDA 510(k) clearances by year

22011

12012

52015

12021

12022

12024

12025

FDA listed device types

Catheters, Transluminal Coronary Angioplasty, Percutaneous 1Catheter, Continuous Flush 1Catheter, Percutaneous 1Catheter, Angioplasty, Peripheral, Transluminal 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251915	Amethyst HP PTA OTW 0.035 Catheter	2025-12-18
US	K241040	Amethyst HP PTA OTW 0.035 Catheter	2024-12-18
US	K220410	Ebony HP PTA OTW 0.035 Catheter	2022-06-29
BR	80984199024	Cateter Balão PTA HP Amethyst	Class II
BR	80984199025	Cateter balão PTA OTW N/C Ebony HP	Class II
BR	81504799255	NYLOTRACK PTA-BALOON CATHETER	Class II
CA	90631	EBONY PTA-RX BALLOON CATHETERS	Class IV
CA	90632	EBONY PTA-OTW BALLOON CATHETERS	Class IV
CA	90914	PTCA-RX BALLOON CATHETERS	Class IV

Natec Medical , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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