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Human Papillomavirus Genotyping Real Time PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref JC80301NWRef JC80301NW-48T
Identity
- Trade Name
- Human Papillomavirus Genotyping Real Time PCR Kit EUDAMED
- Device Name
- Human Papillomavirus Genotyping Real Time PCR Kit EUDAMED
- Model / Reference
- JC80301NW EUDAMEDJC80301NW-48T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-JC80301NW-24TVJ EUDAMEDD-JC80301NW-48TW8 EUDAMED
- Basic UDI-DI
- B-JC80301NW-24TVJ EUDAMEDB-JC80301NW-48TW8 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
Yes
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 Genotyping Real Time PCR Kit by Jiangsu Bioperfectus Technologies 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-JC80301NW-24TVJ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Bioperfectus Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000014691
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 0d069d2c-4318-424b-8ce0-07b3170d3c6d 61 fields · synced Jul 10, 2026
- EUDAMED bbc84da1-d00b-4f26-bc77-754f2c628f9b 61 fields · synced May 18, 2026