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OrbusNeich Medical (Shenzhen) Co., Ltd.

China · Shenzhen

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 4Class III 1

plus 15 registration records and 13 510(k), 10 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class II 9

15 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

10 including historic records

TWTaiwanTFDA

3valid device licences

Class II 3

SGSingaporeHSA SMDR

11device registrations

CLASS B 1CLASS D 10

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

10active ARTG entries

Class III 8IIa 2

HKHong KongMDACS

15valid listings

Class II 5Class IV 10

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 3 2

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 States15 registration records, 13 510(k), 10 PMA, 2 excluded

Brazil9 confirmed, 0 excluded

Manufacturer names merged into this page: OrbusNeich Medical (Shenzhen) Co., Ltd. · ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. · ORBUSNEICH MEDICAL (SHENZHEN)CO., LTD.

FDA 510(k) clearances by year

22011

12016

12017

22020

12021

42024

12025

12026

FDA listed device types

Catheters, Transluminal Coronary Angioplasty, Percutaneous 1Catheter, Percutaneous 1Catheter, Percutaneous, Cutting/Scoring 1Catheter, Angioplasty, Peripheral, Transluminal 1Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253361	Teleport Glide Microcatheter	2026-04-10
US	K242588	COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)	2025-01-07
US	K233499	Sapphire NC ULTRA Coronary Dilatation Catheter	2024-08-16
BR	80117589152	JADE PLUS PTA Balloon Dilatation Catheter	Class II
BR	80117589153	Teleport Glide Microcatheter	Class II
BR	80117589070	CATETER DE DILATAÇÃO COM BALÃO PARA PTA JADE	Class II

OrbusNeich Medical (Shenzhen) Co., 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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