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SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test
EUDAMEDClass IVD General (EU MDR)
Ref IRT-545
Identity
- Trade Name
- SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test EUDAMED
- Device Name
- SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test EUDAMED
- Model / Reference
- IRT-545 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983134897 EUDAMED
- Basic UDI-DI
- B-06936983134897 EUDAMED
- EMDN Code
- W0105070599 MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test by Hangzhou AllTest Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06936983134897 | Class IVD General | Unknown |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 3e20cfee-dc91-4d10-a65e-6ccd878db68e 61 fields · synced May 23, 2026