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Spacelabs Healthcare Ltd

United Kingdom (ex Northern Ireland)·GB-MF-000001196

Last updated May 23, 2026

Information

Country: United Kingdom (ex Northern Ireland)
Address: Unit B, Foxholes Centre, Hertford, United Kingdom (ex Northern Ireland)
Website: www.spacelabshealthcare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +44(0)01992507700
PRRC Contact: Roger Moldon
EUDAMED SRN: GB-MF-000001196
FDA FEI Number: —
DUNS Number: —

Catalogue (39)

Device	Model / Reference	Registries	Class	Status
4 Electrode Evo Recorder Packed	50-0034	EUDAMEDFDA UDI	Class IIa	Active
Cuff, Abp, Child, 12-20cm/5-8in, No Ltx	015-0118-05Q	EUDAMEDFDA UDI	Class I	Active
Evo Docking Station Usb Conn & Uk Cbl	50-0169	EUDAMEDFDA UDI	Class IIa	Active
Lifescreen Pro Analyser, V1.x	LSPRO	EUDAMEDFDA UDI	Class IIa	Active
Eclipse Pro, Defib Cable, Px, 3 Snap, Long	700-0390-00	EUDAMEDFDA UDI	Class I	Active
Eclipse Pro Recorder, Multilingual	98700	EUDAMEDFDA UDI	Class IIa	Active
Leadwires, Snap, 60cm, 6set, Safety, Aha Holter Code	19-7509	EUDAMEDFDA UDI	Class I	Active
Cuff, Abp, Adult, Xl, 38-50cm/15-20in, No Ltx	016-0109-05Q	EUDAMEDFDA UDI	Class I	Active
Sentinel Cardiology Information Management System	K152881	FDA 510(k)	Class II	Active
Spacelabs Model 90217a Ambulatory Blood Pressure (abp) Monitor	K103732	FDA 510(k)	Class II	Active
Eclipse MINI Model 98900	K212317	FDA 510(k)	Class II	Active
Spacelabs Lifescreen PRO Analyzer	K201921	FDA 510(k)	Class II	Active
Spacelbs Model On Trak (90227) Ambulatory Bloody Pressure (abp) Non-Invasive	K141113	FDA 510(k)	Class II	Active
Spacelabs Pathfinder Sl Holter Analyzer	K110001	FDA 510(k)	Class II	Active
Spacelabs Bleasesirius Anesthesia Workstation	K101850	FDA 510(k)	Class II	Active
Spacelabs Healthcare Cardioexpress	K130207	FDA 510(k)	Class II	Active
Sentinel Software V11	98201	EUDAMEDFDA UDI	Class IIa	Active
Abp Ultralite Monitor, German	90217A-2	EUDAMEDFDA UDI	Class IIa	Active
Pathfinder Sl Holter Analysis System (english)	98000-01	EUDAMEDFDA UDI	Class IIa	Active
Cuff, Abp, Adult M, 24-32cm/9-13in, No Ltx	015-0068-06Q	EUDAMEDFDA UDI	Class I	Active
Pathfinder Sl Analyser	98000SL	EUDAMEDFDA UDI	Class IIa	Active
Cuff, Abp, Adult, S, 17-26cm/7-10in, No Ltx	015-0067-05Q	EUDAMEDFDA UDI	Class I	Active
Eclipse Mini Recorder, Multilingual, Loan	98900-L	EUDAMEDFDA UDI	Class IIa	Active
Eclipse Pro, Defib Cable, Px, 4 Snap, Short	700-0395-00	EUDAMEDFDA UDI	Class I	Active
Eclipse Pro, Cable, Px, 3 Snap, Short	700-0378-00	EUDAMEDFDA UDI	Class I	Active
90227, Ontrak (tummel)	90227-1	EUDAMEDFDA UDI	Class IIa	Active
Universal Cuff Cover Large	706-0183-00	EUDAMEDFDA UDI	Class I	Active
Eclipse Mini	712-1053-02	EUDAMEDFDA UDI	Class I	Active
Cuff, Abp, Adult, S, 17-26cm/7-10in, No Ltx	015-0067-06Q	EUDAMEDFDA UDI	Class I	Active
Evo Docking Station Usb Conn & Eu Pwr Cbl	50-0044	EUDAMEDFDA UDI	Class I	Active
Lifecard Cf Digital Holter Mon	LCF	EUDAMEDFDA UDI	Class I	Active
Eclipse Pro, Cable, Px, 3 Snap, Long	700-0372-00	EUDAMEDFDA UDI	Class I	Active
Abp Ontrak Monitor, German	90227-2	EUDAMEDFDA UDI	Class IIa	Active
Cuff, Abp, Adult, L, 32-42cm/13-17in, No Ltx	016-0077-06Q	EUDAMEDFDA UDI	Class I	Active
Eclipse Pro, Defib Cable, Px, 3 Snap, Short	700-0392-00	EUDAMEDFDA UDI	Class I	Active
Eclipse Mini Recorder, Multilingual	98900	EUDAMEDFDA UDI	Class IIa	Active
Evo Docking Station Usb Conn & Us Cbl	50-0045	EUDAMEDFDA UDI	Class IIa	Active
Eclipse Mini	712-1053-01	EUDAMEDFDA UDI	Class I	Active
Universal Cuff Cover Standard	706-0182-00	EUDAMEDFDA UDI	Class I	Active

Related Companies

Authorised Representatives

MediMark Europe Sarl. FR

Importers

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Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Spacelabs Healthcare Inc. Snoqualmie, WA · US FEI 3010157426