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AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit
EUDAMEDClass B (EU MDR)
Ref NCVM2-1111
Identity
- Trade Name
- AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit EUDAMED
- Device Name
- AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit EUDAMED
- Model / Reference
- NCVM2-1111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809537077866 EUDAMED
- Basic UDI-DI
- 880953707NCVM21111JH EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit by Bioneer Corporation — Class B — 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 | 880953707NCVM21111JH | Class B | Active |
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Manufacturer
- Manufacturer
- BIONEER Corporation
- EUDAMED SRN
- KR-MF-000018672
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED bacbe636-c647-4e20-bdb3-b33638203937 61 fields · synced Jun 19, 2026