Identity
- Trade Name
- NatQal B19-L EUDAMED
- Device Name
- NatQal 2 EUDAMED
- Model / Reference
- 247900 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760369291972 EUDAMED
- Basic UDI-DI
- 376036929DGV0029M EUDAMED
- Unit of Use DI
- 03760369291989 EUDAMED
- EMDN Code
- W0105080808 ALL INFECTIOUS DISEASES CONTROLS - NAT EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
NatQal B19-L by Etablissement Francais Du Sang — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 376036929DGV0029M | Class B | Active |
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Manufacturer
- Manufacturer
- Etablissement Francais Du Sang
- EUDAMED SRN
- FR-MF-000013221
Sources (1)
- EUDAMED ca5e2102-458d-45e8-8182-ec0368782ce7 61 fields · synced Oct 8, 2026