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HPV (16/18 genotypes) DNA TEST (Real-Time PCR)
EUDAMEDClass IVD General (EU MDR)
Ref DA0540Model 48 tests/kit
Identity
- Device Name
- HPV (16/18 genotypes) DNA TEST (Real-Time PCR) EUDAMED
- Model / Reference
- 48 tests/kit EUDAMEDDA0540 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928103005408 EUDAMED
- Basic UDI-DI
- B-06928103005408 EUDAMED
- EMDN Code
- W0105041005 OTHER HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
HPV (16/18 genotypes) DNA TEST (Real-Time PCR) by Daan Gene 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-06928103005408 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Daan Gene Co., Ltd.
- EUDAMED SRN
- CN-MF-000025799
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 865106d4-0970-4aba-86e4-ec81bc995601 61 fields · synced Aug 4, 2026