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Prosigna Breast Cancer Prognostic Gene Signature Assay
EUDAMEDClass IVD General (EU MDR)
Ref PROSIGNA-002; PROSIGNA-003; PROSIGNA-004; PROSIGNA-010
Identity
- Device Name
- Prosigna Breast Cancer Prognostic Gene Signature Assay EUDAMED
- Model / Reference
- PROSIGNA-002; PROSIGNA-003; PROSIGNA-004; PROSIGNA-010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850024414044 EUDAMED
- Basic UDI-DI
- B-00850024414044 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
Prosigna Breast Cancer Prognostic Gene Signature Assay by Veracyte, Inc — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-00850024414044 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Veracyte, Inc
- EUDAMED SRN
- US-MF-000048711
- Authorised Representative
- Veracyte Global BV NL-AR-000047758
Sources (2)
- EUDAMED 30718ce1-bfd3-4b7d-88fb-8c895dcadc98 61 fields · synced Oct 6, 2026
- EUDAMED 30718ce1-bfd3-4b7d-88fb-8c895dcadc98-1 61 fields · synced Jul 13, 2026