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Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit
EUDAMEDClass C (EU MDR)
Ref RT6005
Identity
- Trade Name
- Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit EUDAMED
- Device Name
- Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit EUDAMED
- Model / Reference
- RT6005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954414751864 EUDAMED
- Basic UDI-DI
- 695441479706KS EUDAMED
- EMDN Code
- W0105070304 INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Akso SARS-CoV-2/FluA/FluB Real-time RT-PCR Kit by Getein Biotech, Inc. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 695441479706KS | Class C | Active |
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Manufacturer
- Manufacturer
- Getein Biotech, Inc.
- EUDAMED SRN
- CN-MF-000017986
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e14e898b-49d9-491b-8fee-fe344ea4401b 61 fields · synced Aug 2, 2026