← Back to catalogue
Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Pr…
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref DA0041Model Large package, 48 tests/kit
Identity
- Device Name
- Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- Large package, 48 tests/kit EUDAMEDDA0041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103000410 EUDAMED
- Basic UDI-DI
- B-06928103000410 EUDAMED
- EMDN Code
- W0105020216 HEPATITIS B VIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD Annex II List A EUDAMED
- Market of Registration
- Slovakia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Pr… by Daan Gene Co., Ltd. — Class IVD Annex II List A — IVDD — listed in EUDAMED
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-06928103000410 | Class IVD Annex II List A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 267062f3-4d41-4d6d-83f9-d0974ff5d502 61 fields · synced Jul 10, 2026