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PilotTM Multiple Respiratory Pathogens Digital PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref 2000260Model RP01
Identity
- Device Name
- PilotTM Multiple Respiratory Pathogens Digital PCR Kit EUDAMED
- Model / Reference
- RP01 EUDAMED2000260 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975578360297 EUDAMED
- Basic UDI-DI
- B-06975578360297 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - 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
PilotTM Multiple Respiratory Pathogens Digital PCR Kit 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-06975578360297 | 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 38849f70-d6c1-45e1-adf7-82869acb01c4 61 fields · synced Jun 18, 2026