Nidek Medical Oxygen Concentrators
- Risk class
- Class IIb
- CND nomenclatures code
- Z12159004
- Trade name
- Mark 5 Nuvo 8
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00038214001193
- Basic UDI
- 00038214NIDEK4L
- Version date
- August 08, 2024
- Manufacturer last update
- July 27, 2023
- Active status
- Yes
- Manufacturer name
- Nidek Medical Products Inc.
- Country
- United States
- Country type
- NON_EU
- Address
- 3949 Valley East Industrial Drive Birmingham
- info@nidekmedical.com
- Name
- mdi Europa GmbH
- SRN
- DE-AR-000006218
- Country
- Germany
- Address
- 71 Langenhagener Straße Langenhagen
- info@mdi-europa.com
- 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
- Human tissues
- No
- Animal tissues
- No
OXYGEN CONCENTRATORS
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.