Manufacturer

Remote Diagnostic Technologies

United Kingdom (ex Northern Ireland)Legal entities : Remote Diagnostic Technologies Ltd.

Markets : Belgium · Denmark · France · Germany · Luxembourg · Netherlands · Norway · Sweden · United States

Approvals : EU – class I, IIb · United States (FDA) – 510(k) : 12 · class II · latest in 2020 · see on the FDA website

EU representative : Philips Medical Systems Nederland B.V. (Netherlands)

6 categories, 16 models including 12 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Multi-parameter monitors - other	Z1203020299	IntelliSpace Corsium Crew 01-2508 Tempus IC2 Li-ion Battery2 refs Tempus LS Mount2 refs Tempus Pro Configuration Utility Software 01-2501	I MDR	EUDAMED record Report an error
Transportable/portable multi-parameter patient monitors	Z1203020202	Tempus Pro Patient Monitor 00-1007-R / 86742193/42 Tempus Pro Patient Monitor 00-1024-R / 86742293/42 Tempus Pro Patient Monitor 00-1026-R / 86742393/42 Tempus IC2 00-2001-R93/42 (no longer marketed) Tempus Pro Patient Monitor 00-1004-R / 86742093/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error
Electrocardiographs - hardware accessories	Z12050380	12-Lead ECG Cable (IEC) 6ft3 refs ECG Harness 01-2001	I MDR	EUDAMED record Report an error
Invasive blood pressure monitoring instruments	Z1203020301	Invasive Pressure Adaptor 2 Channel- Edwards TruWave 8ft3 refs 2-Channel Invasive Pressure Module 01-201793/42 (no longer marketed)	I, IIb MDR, 93/42	EUDAMED record Report an error
Multi-parameter monitors - software accessories	Z1203020282	IntelliSpace Corsium 01-250793/42 i2i Real-Time Telemedicine Response Centre Software 01-250693/42 (no longer marketed)	IIb 93/42	EUDAMED record Report an error
Electrocardiographs - consumables	Z12050385	Tempus Pro Printer Paper with 110mm Grid 01-218693/42	I 93/42	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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