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Thermal Recording Chart Paper with Measuring Function - EUDAMED Registration 00009336009466

Access comprehensive regulatory information for Thermal Recording Chart Paper with Measuring Function 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 00009336009466 and manufactured by Graphic Controls Acquisition Corp d.b.a Nissha Medical Technologies in United States.

This page provides complete registration details including trade name (GE Healthcare), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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
00009336009466
No
Thermal Recording Chart Paper with Measuring Function
Trade Name: GE Healthcare
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Device Description (EMDN)

DIAGNOSTIC REGISTRATION PAPERS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z1302
Trade Name
GE Healthcare
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
00009336009466
Basic UDI
009336Measuring-ChartGKS
Version Date
February 25, 2025
Manufacturer Last Update
October 08, 2024
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
400 Exchange Street Buffalo, New York
Email
animkar@nisshamedical.com
Authorized Representative
SRN
FR-AR-000009795
Country
France
Address
23-25 Boulevard de la Paix Cergy
Email
FRquality@nisshamedical.com
Telephone
+33 1 39 72 66 66
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
France
Device Characteristics
Human Tissues
No
Animal Tissues
No