← Back to catalogue
Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Ebola-Zaire
EUDAMEDClass IVD General (EU MDR)
Ref A2532-50TRef A2532-25TRef ID006Ref ID007
Identity
- Device Name
- Duplex Real-Time PCR Diagnostic Kit for Rapid Detection of Ebola-Zaire EUDAMEDDuplex Real-Time PCR Diagnostic Kit for Rapid Detection of Coxsackievirus A16 and Human Enterovirus 71 EUDAMEDDuplex Real-Time PCR Diagnostic Kit for Rapid Detection of Influenza Viruse A and Influenza Viruse B EUDAMED
- Model / Reference
- A2532-50T EUDAMEDA2532-25T EUDAMEDID006 EUDAMEDID007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323012252 EUDAMED06974323012245 EUDAMED06974323012689 EUDAMED06974323012702 EUDAMED
- Basic UDI-DI
- B-06974323012252 EUDAMEDB-06974323012245 EUDAMEDB-06974323012689 EUDAMEDB-06974323012702 EUDAMED
- EMDN Code
- W0105040528 EBOLA (FILOVIRUS) - NA REAGENTS EUDAMEDW0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMEDW0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX 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 Diagnostic Kit for Rapid Detection of Ebola-Zaire by Beijing Applied Biological Technologies Co., Ltd. — Class IVD General — IVDD…
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-06974323012252 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (4)
- EUDAMED 8999a1b9-15ac-4605-86c0-cc8fa11f443a 61 fields · synced Jul 15, 2026
- EUDAMED 357c24ef-1435-4354-bada-dcb2dc4c0c09 61 fields · synced May 18, 2026
- EUDAMED b49a0ec7-3e7e-40dc-baf0-e2f5ef002ef4 61 fields · synced Jul 13, 2026
- EUDAMED 85c0bca5-68bf-41ca-8850-5420c63401a5 61 fields · synced Jul 15, 2026