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IC2 12-Lead ECG Harness - EUDAMED Registration 05060472440464

Access comprehensive regulatory information for IC2 12-Lead ECG Harness 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 05060472440464 and manufactured by Remote Diagnostic Technologies Ltd. in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (ECG Harness), 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
05060472440464
Yes
IC2 12-Lead ECG Harness
Trade Name: ECG Harness
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Device Description (EMDN)

ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12050380
Trade Name
ECG Harness
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060472440464
Basic UDI
506047244BM733VC
Version Date
January 07, 2025
Manufacturer Last Update
May 21, 2024
Active Status
Yes
Manufacturer
Country
United Kingdom (ex Northern Ireland)
Country Type
NON_EU
Address
Aerospace Boulevard Farnborough
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
Luxembourg
Device Characteristics
Human Tissues
No
Animal Tissues
No