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Nidek Medical Oxygen Concentrators - EUDAMED Registration 00038214001193

Access comprehensive regulatory information for Nidek Medical Oxygen Concentrators in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00038214001193 and manufactured by Nidek Medical Products Inc. in United States.

This page provides complete registration details including trade name (Mark 5 Nuvo 8), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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 IIb
00038214001193
Yes
Nidek Medical Oxygen Concentrators
Trade Name: Mark 5 Nuvo 8
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Device Description (EMDN)

OXYGEN CONCENTRATORS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
Z12159004
Trade Name
Mark 5 Nuvo 8
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00038214001193
Basic UDI
00038214NIDEK4L
Version Date
August 08, 2024
Manufacturer Last Update
July 27, 2023
Active Status
Yes
Manufacturer
Country
United States
Country Type
NON_EU
Address
3949 Valley East Industrial Drive Birmingham
Email
info@nidekmedical.com
Authorized Representative
SRN
DE-AR-000006218
Country
Germany
Address
71 Langenhagener StraรŸe Langenhagen
Email
info@mdi-europa.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Belgium:2023-10-22~None, Croatia:2023-10-22~None, Czechia:2023-10-22~None, France:2023-10-22~None, Germany:2023-10-22~None, Greece:2023-10-22~None, Italy:2023-10-22~None, Lithuania:2023-10-22~None, Poland:2023-10-22~None, Romania:2023-10-22~None, Spain:2023-10-22~None, Sweden:2023-10-22~None
Device Characteristics
Human Tissues
No
Animal Tissues
No