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Healthstats International Pte. , Ltd.

Singapore · Singapore

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Russia — 3 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

7510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

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

5active device licences

Class II 5

6 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States0 registration records, 7 510(k), 0 PMA

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: HEALTHSTATS INTERNATIONAL PTE. LTD.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K173028	BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software	2018-06-21
US	K131916	BPROSOFT CASP PC SOFTWARE	2014-03-11
US	K131788	HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE	2014-03-04
CA	76375	OSCILLOMETRIC BLOOD PRESSURE MONITOR WITH MEMORY, MODEL MC3100	Class II
CA	76880	A-PULSE CASP PULSE WAVE ANALYSIS SYSTEM	Class II
CA	76881	BPRO AMBULATORY BLOOD PRESSURE MONITORING SYSTEM	Class II

Healthstats International Pte. , Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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