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Shanghai Institute of Medical Device Testing

China · 上海

✓ Record-verifiedregistrations found in 1 marketsUnified social credit code 12310000729465611F

This company has registrations in United States — 1 overseas markets. No China NMPA registrations were found.

Registrations by market

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

CNChinaNMPA

0China registrations

as of 2026-09-01

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

6510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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.

European Union66 raw hits, 66 excluded, 0 confirmed

United States0 registration records, 6 510(k), 0 PMA, 13 excluded

China0 certificates (Class III 0 / II 0 / I 0), as of 2026-09-01

United Kingdom0 confirmed, 2 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Regulatory identity

Unified social credit code: 12310000729465611F
Exhibition record: CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Market	Identifier	Name	Class / date
US	K082205	FACTOR VIII ANTIBODY SCREEN	2008-11-20
US	K071781	PF4 IGG	2007-12-19
US	K053559	PF4 ENHANCED SOLID PHASE ELISA	2006-01-20

Shanghai Institute of Medical Device Testing

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

Registration details (sample)

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