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Multiple Real-Time PCR Detection Kit for Norovirus GI/GII
EUDAMEDClass IVD General (EU MDR)
Ref A2602YH-50TRef A2602YH-25TRef ID042Ref ID043
Identity
- Device Name
- Multiple Real-Time PCR Detection Kit for Norovirus GI/GII EUDAMEDReal-time PCR Detection Kit for Norovirus GI EUDAMEDReal-time PCR Detection Kit for Norovirus GII EUDAMED
- Model / Reference
- A2602YH-50T EUDAMEDA2602YH-25T EUDAMEDID042 EUDAMEDID043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012320 EUDAMED06974323012313 EUDAMED06974323010906 EUDAMED06974323010920 EUDAMED06974323010913 EUDAMED06974323010890 EUDAMED
- Basic UDI-DI
- B-06974323012320 EUDAMEDB-06974323012313 EUDAMEDB-06974323010906 EUDAMEDB-06974323010920 EUDAMEDB-06974323010913 EUDAMEDB-06974323010890 EUDAMED
- EMDN Code
- W0105040516 NOROVIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
Multiple Real-Time PCR Detection Kit for Norovirus GI/GII by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06974323012320 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (6)
- EUDAMED 69875e99-1389-425c-9f26-36611499bc45 61 fields · synced Sep 30, 2026
- EUDAMED c9e3678e-5702-4130-b962-84ed1cf012f2 61 fields · synced May 17, 2026
- EUDAMED cfeee09d-be80-4b15-a529-118d889758e6 61 fields · synced Jun 18, 2026
- EUDAMED 729d146f-3a36-4a65-a90a-6c2108847fd9 61 fields · synced Jul 10, 2026
- EUDAMED 61f2186b-8026-43b2-9d96-a43681efa99c 61 fields · synced Jul 17, 2026
- EUDAMED efac1a51-7faf-4f9d-8e05-2ad9dba4ffcf 61 fields · synced Aug 2, 2026