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
- 00038214000929
- Basic UDI-DI Code
- B-00038214000929
- Reference
- 925GC
- 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 - Private Labelled
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
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).
Coiled Tubing
Device
EU MDD
·
Eu Md Class 2a
·Liebel-Flarsheim Company, LLC ·On the market·2 countries
Sterivap HP
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·9 countries
Sterivap
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·9 countries
Selectomat SL
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·2 countries
Sterivap SL
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·7 countries
Unisteri HP
Device
EU MDD
·
Eu Md Class 2a
·BMT Medical Technology s.r.o.·On the market·8 countries