Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇭🇺 Hungary
Holotype HLA 24/7 - Configuration A4 & CE v2
Devices (same UDI-DI)
1
Certificates
1
Countries
8
Notified Bodies
1
Basic Information
- Primary DI
- 05999565780203
- Basic UDI-DI Code
- B-05999565780203
- Reference
- H60
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Omixon Biocomputing Ltd.
Additional Description
HLA typing Assay by NGS
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01030499 | TISSUE TYPING REAGENTS - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE 694131 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
🇧🇪 Belgium
🇧🇬 Bulgaria
🇩🇪 Germany
🇩🇰 Denmark
🇫🇷 France
🇭🇺 Hungary
🇮🇹 Italy
🇸🇮 Slovenia
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