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DIGITRAK XT PATIENT CABLE S/M/L - EUDAMED Registration 00884838032958

Access comprehensive regulatory information for DIGITRAK XT PATIENT CABLE S/M/L in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00884838032958 and manufactured by Philips Medical Systems in United States.

This page provides complete registration details including trade name (DigiTrak XT Patient Cable Medium), 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 I
00884838032958
Yes
DIGITRAK XT PATIENT CABLE S/M/L
Trade Name: DigiTrak XT Patient Cable Medium
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Device Description (EMDN)

HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12050480
Trade Name
DigiTrak XT Patient Cable Medium
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
00884838032958
Basic UDI
0884838BM513SU
Active Status
Yes
Manufacturer
Manufacturer Name
Philips Medical Systems
Country
United States
Country Type
NON_EU
Address
3000 Minuteman Road Andover
Email
eudamed@philips.com
Authorized Representative
SRN
NL-AR-000001422
Country
Netherlands
Address
6 Veenpluis Best
Email
EU.Auth.Rep@philips.com
Telephone
n/a
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
Market Available
Austria:2008-03-25~9999-12-31, Belgium:2008-03-25~9999-12-31, Bulgaria:2008-03-25~9999-12-31, Cyprus:2008-03-25~9999-12-31, Czechia:2008-03-25~9999-12-31, Germany:2008-03-25~9999-12-31, Denmark:2008-03-25~9999-12-31, Estonia:2008-03-25~9999-12-31, Spain:2008-03-25~9999-12-31, Finland:2008-03-25~9999-12-31, France:2008-03-25~9999-12-31, Greece:2008-03-25~9999-12-31, Croatia:2008-03-25~9999-12-31, Hungary:2008-03-25~9999-12-31, Ireland:2008-03-25~9999-12-31, Italy:2008-03-25~9999-12-31, Lithuania:2008-03-25~9999-12-31, Luxembourg:2008-03-25~9999-12-31, Latvia:2008-03-25~9999-12-31, Malta:2008-03-25~9999-12-31, Netherlands:2008-03-25~9999-12-31, Poland:2008-03-25~9999-12-31, Portugal:2008-03-25~9999-12-31, Romania:2008-03-25~9999-12-31, Sweden:2008-03-25~9999-12-31, Slovenia:2008-03-25~9999-12-31, Slovakia:2008-03-25~9999-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No