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RoboGene HBV DNA Quantification Kit 3.0
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref 847-0207710192
Identity
- Device Name
- RoboGene HBV DNA Quantification Kit 3.0 EUDAMED
- Model / Reference
- 847-0207710192 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04262386730094 EUDAMED
- Basic UDI-DI
- B-04262386730094 EUDAMED
- EMDN Code
- W0105020216 HEPATITIS B VIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
RoboGene HBV DNA Quantification Kit 3.0 by Roboscreen GmbH — Class IVD Annex II List A — 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-04262386730094 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- Roboscreen GmbH
- EUDAMED SRN
- DE-MF-000024661
Sources (1)
- EUDAMED ac8c176e-1f59-4916-ae00-f3bb30544264 61 fields · synced Jul 14, 2026