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Pressure Diffusing Mattress - EUDAMED Registration 00840682146869

Access comprehensive regulatory information for Pressure Diffusing Mattress 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 00840682146869 and manufactured by Datex-Ohmeda Inc. in United States.

This page provides complete registration details including trade name (Pressure Diffusing Mattress), 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
00840682146869
No
Pressure Diffusing Mattress
Trade Name: Pressure Diffusing Mattress
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Device Description (EMDN)

NEONATOLOGY AND PEDIATRICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V028099
Trade Name
Pressure Diffusing Mattress
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840682146869
Basic UDI
8406821BUG00158HG
Version Date
January 08, 2025
Manufacturer Last Update
December 26, 2024
Active Status
No
Manufacturer
Manufacturer Name
Datex-Ohmeda Inc.
Country
United States
Country Type
NON_EU
Address
9900 Innovation Drive Wauwatosa
Email
CoE.Postmarket@gehealthcare.com
Authorized Representative
SRN
FR-AR-000000344
Country
France
Address
283 Rue de la Miniere BUC
Email
eudamed@gehealthcare.com
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
Austria
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Czechia:None~None, France:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Latvia:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Tรผrkiye:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No