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Electrocardiographic Electrodes Cardinal - EUDAMED Registration 20884838000876

Access comprehensive regulatory information for Electrocardiographic Electrodes Cardinal 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 20884838000876 and manufactured by Philips Medical Systems in United States.

This page provides complete registration details including trade name (NEONATAL/PEDIATRIC SOLID GEL ELECTRODE), 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
20884838000876
No
Electrocardiographic Electrodes Cardinal
Trade Name: NEONATAL/PEDIATRIC SOLID GEL ELECTRODE
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Device Description (EMDN)

TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z1203020202
Trade Name
NEONATAL/PEDIATRIC SOLID GEL ELECTRODE
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
20884838000876
Basic UDI
0884838BM532SY
Version Date
February 12, 2025
Manufacturer Last Update
May 21, 2024
Active Status
No
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:2008-09-10~9999-12-31, Belgium:2008-09-10~9999-12-31, Bulgaria:2008-09-10~9999-12-31, Cyprus:2008-09-10~9999-12-31, Czechia:2008-09-10~9999-12-31, Germany:2008-09-10~9999-12-31, Denmark:2008-09-10~9999-12-31, Estonia:2008-09-10~9999-12-31, Spain:2008-09-10~9999-12-31, Finland:2008-09-10~9999-12-31, France:2008-09-10~9999-12-31, Greece:2008-09-10~9999-12-31, Croatia:2008-09-10~9999-12-31, Hungary:2008-09-10~9999-12-31, Ireland:2008-09-10~9999-12-31, Italy:2008-09-10~9999-12-31, Lithuania:2008-09-10~9999-12-31, Luxembourg:2008-09-10~9999-12-31, Latvia:2008-09-10~9999-12-31, Malta:2008-09-10~9999-12-31, Netherlands:2008-09-10~9999-12-31, Norway:2008-09-10~9999-12-31, Poland:2008-09-10~9999-12-31, Portugal:2008-09-10~9999-12-31, Romania:2008-09-10~9999-12-31, Sweden:2008-09-10~9999-12-31, Slovenia:2008-09-10~9999-12-31, Slovakia:2008-09-10~9999-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No