← Back to catalogue
Invasive Fungal Nucleic Acid Detection Kit (Digital PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 2000244Model P09
Identity
- Device Name
- Invasive Fungal Nucleic Acid Detection Kit (Digital PCR Method) EUDAMED
- Model / Reference
- P09 EUDAMED2000244 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975578360150 EUDAMED
- Basic UDI-DI
- B-06975578360150 EUDAMED
- EMDN Code
- W0105070599 MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER 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
Invasive Fungal Nucleic 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-06975578360150 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pilot Gene Technology (Hangzhou) Co., Ltd
- EUDAMED SRN
- CN-MF-000023002
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 77a659c6-b27a-4b7a-9a13-0342586a6dcc 61 fields · synced Aug 2, 2026