B105P Patient Monitor

Basic UDI-DI

EU MDR · Eu Md Class 2b ·GE Medical Systems Information Technologies, Inc.·5 devices

MAC VU360 and CAM Connect 14

Basic UDI-DI

EU MDR · Eu Md Class 2a ·GE Medical Systems Information Technologies, Inc.·3 devices

CASE V7.0

Basic UDI-DI

EU MDR · Eu Md Class 2a ·GE Medical Systems Information Technologies, Inc.·1 device

Portrait Core Services

Basic UDI-DI

EU MDR · Eu Md Class 2b ·GE Medical Systems Information Technologies, Inc.·1 device

Portrait Central Viewer Application

Basic UDI-DI

EU MDR · Eu Md Class 2b ·GE Medical Systems Information Technologies, Inc.·1 device

Portrait Clinical Alarming Unit

Basic UDI-DI

EU MDR · Eu Md Class 2b ·GE Medical Systems Information Technologies, Inc.·1 device

MAC 5 A4 Resting ECG Analysis System

Basic UDI-DI

EU MDR · Eu Md Class 2a ·GE Medical Systems Information Technologies, Inc.·3 devices

B1X5-REC Recorder

Basic UDI-DI

EU MDR · Eu Md Class 1 ·GE Medical Systems Information Technologies, Inc.·1 device

Donawa Lifescience Consulting Srl

Authorized representative

🇮🇹 Italy·31 Manufacturers·15 Devices

Agilent Technologies Denmark ApS

Authorized representative

🇩🇰 Denmark·3 Manufacturers·176 Devices

Tornier SAS

Authorized representative

🇫🇷 France·2 Manufacturers

eResearchTechnology GmbH

Authorized representative

🇩🇪 Germany·2 Manufacturers

9727-2017-CE-RGC-NA-PS

Certificate

MDD Annex V·TRONJEN MEDICAL TECHNOLOGY INC.·DNV Product Assurance AS·5 Basic UDI-DIs

HZ 2183950-1

Certificate

MDR QMS·Guangdong Optomedic Technologies, Inc.·TÜV Rheinland LGA Products GmbH

CN19/41097

Certificate

MDD Annex II (excluding section 4)·Double Medical Technology Inc.·SGS Belgium NV·1 Basic UDI-DI

CN19/41097

Certificate

MDD Annex II (excluding section 4)·Double Medical Technology Inc.·SGS Belgium NV·1 Basic UDI-DI

G1 102159 0002

Certificate

MDD Annex II (excluding section 4)·Double Medical Technology Inc.·TÜV SÜD Product Service GmbH·5 Basic UDI-DIs

CE 641606

Certificate

MDD Annex II (excluding section 4)·Rad Source Technologies Inc.·BSI Group The Netherlands B.V.·1 Basic UDI-DI

41371607-02

Certificate

MDD Annex V·AccuTech Medical Technologies Inc.·INTERTEK SEMKO AB·13 Basic UDI-DIs

301001848ADDE16

Certificate

MDD Annex II (excluding section 4)·Prollenium Medical Technologies Inc.·NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY·2 Basic UDI-DIs