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Actiware Software, Actiware CT Software - EUDAMED Registration 00606959419797

Access comprehensive regulatory information for Actiware Software, Actiware CT Software in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00606959419797 and manufactured by Respironics Inc. in United States.

This page provides complete registration details including trade name (CT Sanofi LPS15497 Software Pkg Scorer-6), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class IIa
00606959419797
No
Actiware Software, Actiware CT Software
Trade Name: CT Sanofi LPS15497 Software Pkg Scorer-6
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Device Description (EMDN)

METABOLIC AND PHYSICAL ACTIVITY HOLTER SYSTEMS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12040117
Trade Name
CT Sanofi LPS15497 Software Pkg Scorer-6
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00606959419797
Basic UDI
B-00606959419797
Version Date
February 26, 2025
Manufacturer Last Update
May 21, 2024
Active Status
No
Manufacturer
Manufacturer Name
Respironics Inc.
Country
United States
Country Type
NON_EU
Address
1001 Murry Ridge Lane Murrysville
Email
eudamed@philips.com
Authorized Representative
SRN
DE-AR-000006164
Country
Germany
Address
17 Gewerbestrasse Herrsching am Ammersee
Email
EU.Auth.Rep@philips.com
Telephone
n/a
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Austria
Market Available
Austria:2018-05-23~2023-12-31, Belgium:2018-05-23~2023-12-31, Cyprus:2018-05-23~2023-12-31, Czechia:2018-05-23~2023-12-31, Germany:2018-05-23~2023-12-31, Denmark:2018-05-23~2023-12-31, Estonia:2018-05-23~2023-12-31, Spain:2018-05-23~2023-12-31, Finland:2018-05-23~2023-12-31, France:2018-05-23~2023-12-31, Greece:2018-05-23~2023-12-31, Croatia:2018-05-23~2023-12-31, Hungary:2018-05-23~2023-12-31, Ireland:2018-05-23~2023-12-31, Iceland:2018-05-23~2023-12-31, Italy:2018-05-23~2023-12-31, Lithuania:2018-05-23~2023-12-31, Luxembourg:2018-05-23~2023-12-31, Latvia:2018-05-23~2023-12-31, Netherlands:2018-05-23~2023-12-31, Norway:2018-05-23~2023-12-31, Poland:2018-05-23~2023-12-31, Portugal:2018-05-23~2023-12-31, Romania:2018-05-23~2023-12-31, Sweden:2018-05-23~2023-12-31, Slovenia:2018-05-23~2023-12-31, Slovakia:2018-05-23~2023-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No