Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡บ๐Ÿ‡ธ United States

IntelliSpace ECG Management System

Philips Medical Systems ยท ๐Ÿ‡บ๐Ÿ‡ธ United States
Devices (same UDI-DI)
1
Certificates
1
Countries
27
Notified Bodies
1

Basic Information

Primary DI
00884838093478
Basic UDI-DI Code
B-00884838093478
Reference
860426
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

"Provides for the acquisition, processing, storage, and distribution for resting ECGs from Philips PageWriter cardiographs, IntelliVue Monitoring Systems, and Telemedicine Systems as well as for Philips stress and Holter reports. Non-Philips devices optionally supported. Application software only. Does not include Windows Server 2012 or SQL Server 2014. North America: Includes remote software installation in customer-supplied compliant environment. Base editions and base upgrades include standard implementation. Custom or incremental services are quoted by the SCS or local organization with a Statement of Work. International Markets: Implementation services are not included and are quoted separately."

CND Nomenclature Codes

Code Description
Z12059009 ECG DATA MANAGEMENT SYSTEMS

Certificates

Type Number
MDD Annex II (excluding section 4) CL 052098 0016

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ง๐Ÿ‡ฌ Bulgaria ๐Ÿ‡จ๐Ÿ‡พ Cyprus ๐Ÿ‡จ๐Ÿ‡ฟ Czechia ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡ท Croatia ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ฑ๐Ÿ‡น Lithuania ๐Ÿ‡ฑ๐Ÿ‡บ Luxembourg ๐Ÿ‡ฑ๐Ÿ‡ป Latvia ๐Ÿ‡ฒ๐Ÿ‡น Malta ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ต๐Ÿ‡ฑ Poland ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ธ๐Ÿ‡ฎ Slovenia ๐Ÿ‡ธ๐Ÿ‡ฐ Slovakia

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