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One Step Rotavirus Test
EUDAMEDClass IVD General (EU MDR)
Ref RH-ROTAModel strip, cassette
Identity
- Device Name
- One Step Rotavirus Test EUDAMED
- Model / Reference
- strip, cassette EUDAMEDRH-ROTA EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69384449ROTA3Y EUDAMED
- Basic UDI-DI
- B-69384449ROTA3Y EUDAMED
- EMDN Code
- W0105099099 VIROLOGY - RT & POC - OTHER 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
One Step Rotavirus Test by Equinox Biotech Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-69384449ROTA3Y | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Equinox Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000018901
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 9d4dc8a1-a40c-4928-bba0-d8483068f714 61 fields · synced Jun 18, 2026