Spacelabs Healthcare Ltd
GB-MF-000001196 · United Kingdom · Hertford
Spacelabs Healthcare Ltd is registered in the European database on medical devices as a manufacturer, with 31 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 31 |
|---|
Most frequent device types declared: ABP Cuffs and Cuff Covers, EVO Docking Station, Eclipse Mini, Eclipse Pro, Lifecard.
Among these devices, 22 are declared active, 13 with a measuring function.
Authorised representative in the Union: MediMark Europe Sarl..
Devices declared under this manufacturer
- 90227, ONTRAK (TUMMEL)
- ABP ONTRAK MONITOR, GERMAN
- ABP ULTRALITE MONITOR, GERMAN
- CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
- CUFF,ABP,ADULT,S,17-26CM/7-10IN,NO LTX
- ECLIPSE PRO RECORDER,MULTILINGUAL
- ECLIPSE PRO,CABLE,PX,3 SNAP,SHORT
- EVO DOCKING STATION USB CONN & EU PWR CBL
- Eclipse Mini
- LEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE
- LIFECARD CF DIGITAL HOLTER MON
- PATHFINDER SL HOLTER ANALYSIS SYSTEM (ENGLISH)
Showing 12 of 31 declared devices.
Catalogue references include 015-0067-06Q, 712-1053-02, 90217A-2, 90227-1, 90227-2, 98201.
European nomenclature codes declared: Z12050485, Z1203020599, Z12050403, Z12050404, Z12050401, Z12050482.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SPACELABS HEALTHCARE LTD. (GB) · FDA 9611295 |
| Devices in EUDAMED | 31 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 31 |
|---|---|
| Found in the U.S. device database | 31 |
| Share | 100.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SPACELABS HEALTHCARE INC. |
What it holds in Canada
| Licences on record | 30 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 20 |
| Class 3 devices | 10 |
| First licensed | 1999-01-11 |
Licence types: Device Family (24), System (3), Single Device (2), Device Group (1).
Licensed under: BLOOD PRESSURE CUFFS, PATIENT CARE MONITORING SYSTEM - MONITORS, SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMETRY , PATIENT CARE MONITORING SYSTEM - MODULES, MEDICAL GRADE FLAT PANEL DISPLAY WITH TOUCHSCR, SPO2 SENSORS - REUSABLE AND SINGLE PATIENT USE.
North American profile: Both markets. Spacelabs Healthcare Ltd is registered in both the United States and Canada.