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STANDARD™ Q COVID-19 Ag Test 2.0
EUDAMEDClass B (EU MDR)
Ref Q-NCOV-07G/ 09COV175DModel Q-NCOV-07G
Identity
- Device Name
- STANDARD™ Q COVID-19 Ag Test 2.0 EUDAMED
- Model / Reference
- Q-NCOV-07G EUDAMEDQ-NCOV-07G/ 09COV175D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800111715761 EUDAMED
- Basic UDI-DI
- 88001117IPBA02QA04Y2 EUDAMED
- EMDN Code
- W0105090501 CORONAVIRUS ANTIGEN (AG) - RT & POC EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
No
EUDAMED
STANDARD™ Q COVID-19 Ag Test 2.0 by SD Biosensor Inc. — 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 | 88001117IPBA02QA04Y2 | Class B | Active |
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Manufacturer
- Manufacturer
- SD Biosensor Inc.
- EUDAMED SRN
- KR-MF-000009168
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 36a6846f-d67f-4e6a-87b6-a68f4f05bef6 61 fields · synced Aug 1, 2026