Identity
- Device Name
- C2inform EUDAMED
- Model / Reference
- C2inform 1.0.0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-C2informHS EUDAMED
- Basic UDI-DI
- B-C2informHS EUDAMED
- EMDN Code
- W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
C2inform 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-C2informHS | 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 (1)
- EUDAMED aa1162eb-1699-47ae-a5bb-2f1e5d76f6f4 61 fields · synced Jul 31, 2026