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Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)
EUDAMEDClass IVD General (EU MDR)
Ref 210601Ref 212601
Identity
- Trade Name
- Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot) EUDAMED
- Device Name
- Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot) EUDAMED
- Model / Reference
- 210601 EUDAMED212601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955931302966 EUDAMED06955931302959 EUDAMED06955931305011 EUDAMED06955931302973 EUDAMED06955931305035 EUDAMED06955931305042 EUDAMED
- Basic UDI-DI
- B-06955931302966 EUDAMEDB-06955931302959 EUDAMEDB-06955931305011 EUDAMEDB-06955931302973 EUDAMEDB-06955931305035 EUDAMEDB-06955931305042 EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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 Genotyping Kit for 23 Types (PCR-Reverse Dot Blot) by Yaneng BIOscience (Shenzhen) Co., Ltd. — Class IVD General — 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-06955931302966 | 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 (6)
- EUDAMED e2e20796-c164-4188-955f-28ae687dd884 61 fields · synced Aug 2, 2026
- EUDAMED 56f683a5-3a44-41a3-a005-26ab0bca0ae5 61 fields · synced May 17, 2026
- EUDAMED df7b7c07-6642-4368-97f0-919480c85e6e 61 fields · synced May 19, 2026
- EUDAMED d89c9bc6-a50f-49b2-8e28-f42ad48c1f0a 61 fields · synced May 19, 2026
- EUDAMED c520711d-948c-48ac-a8ba-7e7c2d590b96 61 fields · synced May 19, 2026
- EUDAMED 5f46d308-70a1-462e-b9b0-4e1ba1dc70e4 61 fields · synced May 19, 2026