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Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fl…
EUDAMEDClass IVD General (EU MDR)
Ref 2116DF
Identity
- Trade Name
- Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- 2116DF EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931302843 EUDAMED06955931302867 EUDAMED06955931302850 EUDAMED
- Basic UDI-DI
- B-06955931302843 EUDAMEDB-06955931302867 EUDAMEDB-06955931302850 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
Human Papillomavirus Nucleic Acid Detection and HPV16/18 Genotyping Kit (PCR-Fl… by Yaneng BIOscience (Shenzhen) Co., Ltd. — Class IVD General — IVDD — listed…
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-06955931302843 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yaneng BIOscience (Shenzhen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013666
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED a90c2550-6b0d-4e70-be02-068b6993cbc8 61 fields · synced Jul 31, 2026
- EUDAMED f2657cab-b4c8-4af5-ae0b-ae6092924e5b 61 fields · synced May 18, 2026
- EUDAMED 42bf575f-d7f9-4428-8086-408ef7984fe5 61 fields · synced May 19, 2026