Identity
- Device Name
- SAMBA III SCoV-2/Flu/RSV Test EUDAMED
- Model / Reference
- 9000-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B7149000120 EUDAMED
- Basic UDI-DI
- ++B7149000122R EUDAMED
- EMDN Code
- W0105090699 OTHER MULTIPLE PATHOGENS - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
SAMBA III SCoV-2/Flu/RSV Test by Diagnostics for the Real World Ltd — 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 | ++B7149000122R | Class B | Active |
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Manufacturer
- Manufacturer
- Diagnostics for the Real World Ltd
- EUDAMED SRN
- US-MF-000023951
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 7159bdff-dea3-4c68-a54f-d939bef13b7d 61 fields · synced Jun 18, 2026