Eu Mdd
Eu Md Class 2a
On The Market
๐บ๐ธ United States
Mark 5 Nuvo Lite
Devices (same UDI-DI)
1
Certificates
1
Countries
13
Notified Bodies
1
Basic Information
- Primary DI
- 00038214000882
- Basic UDI-DI Code
- B-00038214000882
- Reference
- 925NEB
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Nidek Medical Products Inc.
Additional Description
The Mark 5 Nuvo Lite Oxygen Concentrators provide oxygen enriched product gas, in liter flows from 0.125 to 5 LPM, for patients suffering from health conditions that cause low levels of oxygen in the blood (hypoxaemia). Variant - nebulizer air outlet.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12159004 | OXYGEN CONCENTRATORS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 41312638-02 | INTERTEK SEMKO AB | Expired |
Available In Countries
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฒ๐น Malta
๐ต๐ฑ Poland
๐ท๐ด Romania
๐ธ๐ช Sweden
๐น๐ท Tรผrkiye
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