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Human HerpesvirusNucleic Acid Detection Kit (Digital PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 2000262Model HHV
Identity
- Device Name
- Human HerpesvirusNucleic Acid Detection Kit (Digital PCR Method) EUDAMED
- Model / Reference
- HHV EUDAMED2000262 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975578360303 EUDAMED
- Basic UDI-DI
- B-06975578360303 EUDAMED
- EMDN Code
- W0105070302 OTHER VIRUS COMBINATIONS - MULTIPLEX 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
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 HerpesvirusNucleic Acid Detection Kit (Digital PCR Method) by Pilot Gene Technology (Hangzhou) 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-06975578360303 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Pilot Gene Technology (Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000023002
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED fa5253a6-90cc-4d12-887f-2c41f336ab44 61 fields · synced Jun 18, 2026