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Human Papillomavirus 18 Types Detection Kit (Fluorescence PCR)
EUDAMEDClass IVD General (EU MDR)
Ref AHPV1801-AOG48E
Identity
- Device Name
- Human Papillomavirus 18 Types Detection Kit (Fluorescence PCR) EUDAMED
- Model / Reference
- AHPV1801-AOG48E EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69509960AHPV1801-ASHXU EUDAMED
- Basic UDI-DI
- B-69509960AHPV1801-ASHXU EUDAMED
- EMDN Code
- W0105041004 FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General 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
Human Papillomavirus 18 Types Detection Kit (Fluorescence PCR) by Zhejiang Orient Gene Biotech 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-69509960AHPV1801-ASHXU | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 98bc98be-ee1c-42bb-ac57-7528910fb7cb 61 fields · synced Jun 19, 2026