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Spacelabs Healthcare, Ltd.

United Kingdom of Great Britain and Northern Ireland · Snoqualmie

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 21 510(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

45active device licences

Class II 20Class III 25

94 including historic records

TWTaiwanTFDA

21valid device licences

Class I 1Class II 19Class III 1

SGSingaporeHSA SMDR

11device registrations

CLASS B 6CLASS C 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

7active ARTG entries

Class I 3IIa 3IIb 1

HKHong KongMDACS

7valid listings

Class II 7

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

4active registrations

Class 2b 4

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, 21 510(k), 0 PMA, 3 excluded

Brazil4 confirmed, 0 excluded

Canada45 confirmed, 0 excluded

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

Business registration

Legal name: SPACELABS HEALTHCARE LIMITED
Company number: 00570647
Registration status: Active
Legal form: Private Limited Company
Incorporated: 1956-08-23
Principal activity: 32500 - Manufacture of medical and dental instruments and supplies
Registered address: ONE, LONDON, EC4M 9AF

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12009

62011

42012

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	6946	MICRO V ELECTRODE	Class II
CA	24412	HEARTWAVE ALTERNANS PROCESSING SYSTEM	Class II
CA	27060	EVENT RECORDERS	Class II