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Fogg Patient Monitoring Cable - EUDAMED Registration 00840416601015

Access comprehensive regulatory information for Fogg Patient Monitoring Cable 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 00840416601015 and manufactured by Fogg System Company, Inc. in United States.

This page provides complete registration details including trade name (0464-2531 Interface Cable), 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
00840416601015
No
Fogg Patient Monitoring Cable
Trade Name: 0464-2531 Interface Cable
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Device Description (EMDN)

MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z1203020280
Trade Name
0464-2531 Interface Cable
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840416601015
Basic UDI
8404166CBL001G7
Version Date
March 05, 2025
Manufacturer Last Update
February 19, 2024
Active Status
No
Manufacturer
Manufacturer Name
Fogg System Company, Inc.
Country
United States
Country Type
NON_EU
Address
15592 E Batavia Dr Aurora
Email
compliance@foggsystem.com
Authorized Representative
SRN
NL-AR-000024028
Country
Netherlands
Address
33 Prinses Margrietplantsoen The Hague
Email
EU-AR@medenvoyglobal.com
Telephone
+31 70 326 21 48
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Netherlands
Market Available
Austria:2025-03-03~None, Belgium:2025-03-03~None, Bulgaria:2025-03-03~None, Croatia:2025-03-03~None, Cyprus:2025-03-03~None, Czechia:2025-03-03~None, Denmark:2025-03-03~None, Estonia:2025-03-03~None, Finland:2025-03-03~None, France:2025-03-03~None, Germany:2025-03-03~None, Greece:2025-03-03~None, Hungary:2025-03-03~None, Iceland:2025-03-03~None, Ireland:2025-03-03~None, Italy:2025-03-03~None, Latvia:2025-03-03~None, Liechtenstein:2025-03-03~None, Lithuania:2025-03-03~None, Luxembourg:2025-03-03~None, Malta:2025-03-03~None, Netherlands:2025-03-03~None, Norway:2025-03-03~None, Poland:2025-03-03~None, Portugal:2025-03-03~None, Romania:2025-03-03~None, Slovakia:2025-03-03~None, Slovenia:2025-03-03~None, Spain:2025-03-03~None, Sweden:2025-03-03~None, Tรผrkiye:2025-03-03~None, United Kingdom (Northern Ireland only):2025-03-03~None
Device Characteristics
Human Tissues
No
Animal Tissues
No