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Duplex Real-Time PCR Detection Kit for Coxsackievirus A16 and Human Enterovirus…
EUDAMEDClass IVD General (EU MDR)
Ref CT8022-48TRef ID035Ref ID038
Identity
- Device Name
- Duplex Real-Time PCR Detection Kit for Coxsackievirus A16 and Human Enterovirus 71 EUDAMEDReal-time PCR Detection Kit for Coxsackievirus A16, Enterovirus 71 and Enterovirus EUDAMEDReal-Time PCR Detection Kit for Enterovirus EUDAMED
- Model / Reference
- CT8022-48T EUDAMEDID035 EUDAMEDID038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012122 EUDAMED06974323010593 EUDAMED06974323010791 EUDAMED06974323010586 EUDAMED
- Basic UDI-DI
- B-06974323012122 EUDAMEDB-06974323010593 EUDAMEDB-06974323010791 EUDAMEDB-06974323010586 EUDAMED
- EMDN Code
- W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMEDW0105040502 ENTEROVIRUS - 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
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Duplex Real-Time PCR Detection Kit for Coxsackievirus A16 and Human Enterovirus… by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General…
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-06974323012122 | 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 (4)
- EUDAMED 188295a6-7001-4a21-91db-cde3d8643bc1 61 fields · synced Aug 4, 2026
- EUDAMED 89a9efe7-4849-47ea-9418-09625f419aec 61 fields · synced Jul 17, 2026
- EUDAMED dd2dc93a-b3a8-4bb9-8a21-704602f7f160 61 fields · synced Jul 25, 2026
- EUDAMED 6a23221a-d3a0-456a-8b36-9dd5abdb2fe3 61 fields · synced Aug 4, 2026