Home›SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP.

SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP.

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in Brazil, Saudi Arabia, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 8 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

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

5 including historic records

SASaudi ArabiaSFDA

9registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

9device registrations

CLASS B 7CLASS C 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 1IVD import 1

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

2valid listings

Class II 1Class III 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States0 registration records, 0 510(k), 0 PMA, 18 excluded

Brazil4 confirmed, 8 excluded

Saudi Arabia9 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP. · Shanghai Kohden Medical Eletrical Instrument Corp · Shanghai Kohden Medical Electronic Instrument Corp.

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80914690002	CARDIOFAX M	Class II
BR	80914690025	ECG-2250 - CARDIOFAX S	Class II
BR	80914690012	Isotonac3 MEK-640	Class I
SA	ME0000000331SFDAA00001	SVM-7500 ACCESSORY KIT	—
SA	ME0000000331SFDAA00002	ECG PATIENT CABLE	—

SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP.

Registrations by market

How these numbers were verified

Company information

Registration details (sample)

Similar companies