← Back to catalogue
Real-Time PCR Diagnostic Kit for Human Enterovirus 71 (EV71) (TaqMan probe meth…
EUDAMEDClass IVD General (EU MDR)
Ref A2681
Identity
- Device Name
- Real-Time PCR Diagnostic Kit for Human Enterovirus 71 (EV71) (TaqMan probe method) EUDAMED
- Model / Reference
- A2681 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323011262 EUDAMED06974323011255 EUDAMED
- Basic UDI-DI
- B-06974323011262 EUDAMEDB-06974323011255 EUDAMED
- EMDN Code
- W0105040502 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
Real-Time PCR Diagnostic Kit for Human Enterovirus 71 (EV71) (TaqMan probe meth… 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-06974323011262 | 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 (2)
- EUDAMED 9a35c05f-5842-4a2e-b5dc-a1489b39765a 61 fields · synced Sep 30, 2026
- EUDAMED 3c76af12-ca37-40ed-8496-76aed76b6dfe 61 fields · synced Jul 8, 2026