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Spacelabs Healthcare Medical Equipment (Suzhou) CO

USA · Nederland

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 5 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

36listed device types

Class I 2Class II 34Class III 0

plus 70 registration records and 56 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

35active device licences

Class II 12Class III 23

68 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

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 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 States70 registration records, 56 510(k), 0 PMA, 2 excluded

Brazil4 confirmed, 0 excluded

Canada35 confirmed, 1 excluded

Manufacturer names merged into this page: SPACELABS HEALTHCARE LTD. · Spacelabs Healthcare Inc. · SPACELABS HEALTHCARE INC. · SPACELABS HEALTHCARE, INC. · SPACELABS HEALTHCARE LTD · SPACELABS HEALTHCARE, INC

FDA 510(k) clearances by year

61997

31998

21999

12000

12001

22002

22005

42006

12007

12008

22009

12010

72011

52012

32013

22014

12015

12016

22021

12022

FDA listed device types

showing 8 of 36

System, Network And Communication, Physiological Monitors 1Electrocardiograph, Ambulatory (Without Analysis) 1Detector And Alarm, Arrhythmia 1Index-Generating Electroencephalograph Software 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Electrode, Electrocardiograph 1Antimicrobial Blood Pressure Cuff 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212317	Eclipse MINI Model 98900	2022-11-07
US	K211651	Eclipse PRO	2021-11-22
US	K201921	Spacelabs Lifescreen PRO Analyzer	2021-03-26
BR	80169109006	Sistema de Analise de Holter Eclipse PRO	Class II
BR	80169109007	Monitor de Pressão Arterial Ambulatorial OnTrak 90227	Class II
BR	80169109003	MONITOR AMBULATORIAL DE PRESSÃO ARTERIAL - MAPA	Class II
CA	3731	DOLPHIN OXIMETRY SENSORS AND EXTENSIONS	Class II
CA	4168	ULTRAVIEW ANESTHESIA DELIVERY SYSTEM	Class III
CA	4171	INTRAPARTUM FETAL MONITOR	Class III

Spacelabs Healthcare Medical Equipment (Suzhou) CO

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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