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Idylla™ Console Software Plus (CSW+)
EUDAMEDClass A (EU MDR)
Ref P2040
by Biocartis NV
Identity
- Trade Name
- Idylla™ Console Software Plus (CSW+) EUDAMED
- Device Name
- Idylla™ Console Software Plus (CSW+) EUDAMED
- Model / Reference
- P2040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415219001178 EUDAMED
- Basic UDI-DI
- 5415219P2040HC EUDAMED
- EMDN Code
- W02050182 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Idylla™ Console Software Plus (CSW+) by Biocartis NV — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5415219P2040HC | Class A | Active |
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Manufacturer
- Manufacturer
- Biocartis NV
- EUDAMED SRN
- BE-MF-000003661
Sources (1)
- EUDAMED 0a30ba5c-f1ee-49fb-afbe-75b8f9f6dae3 61 fields · synced Jul 27, 2026