Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇫🇮 Finland
NeoMass AAAC 3.0
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 06438172402010
- Basic UDI-DI Code
- B-06438172402010
- Reference
- NeoMass AAAC 3.0
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
This NeoMass AAAC 3.0 kit is for the quantitative measurement of amino acids, free carnitine, acylcarnitines, argininosuccinic acid, succinylacetone, lysophospholipid and nucleoside in blood samples dried on filter paper as a primary test for screening of newborns for inborn errors of metabolism.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01010402 | MULTIPLE SUBSTRATES ONLY - CLIN. CHEM LAB R. |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | C-02-1172-794-22 | Eurofins Electric & Electronics Finland Oy | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).
master diagnostica
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·VITRO, S.A.·On the market
Vitamin B1 & B6 Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Methylmalonic Acid Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Cortisol & Cortisone Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Vitamin A & E Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market·32 countries
Metanephrines Reagent Set
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Diagnotix B.V.·On the market