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Shanghai MicroPort Medical (Group) Co., Ltd.

China · Shanghai

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, 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

1listed device types

Class I 0Class II 1Class III 0

plus 6 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

7 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class III 1

SGSingaporeHSA SMDR

3device registrations

CLASS D 2D WITH MEDICINAL PRODUCT 1

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

3active ARTG entries

Class III 3

HKHong KongMDACS

6valid listings

Class IV 6

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

6active registrations

Class 3 6

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 States6 registration records, 3 510(k), 0 PMA, 18 excluded

Brazil0 confirmed, 17 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD · SHANGHAI MICROPORT MEDICAL (GROUP) CO., LTD. · Shanghai MicroPort Medical (Group) Co., Ltd · Shangai MicroPort Medical (Group) Co., Ltd.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252116	Firefighter Pro PTCA Balloon Catheter	2026-04-07
US	K223189	Firefighter NC Pro PTCA Balloon Catheter	2023-07-21
US	K143160	FOXTROT NC PTCA Balloon Catheter	2015-03-05

Shanghai MicroPort Medical (Group) 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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