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TruSight™ Oncology Comprehensive (EU) kit
EUDAMEDClass IVD General (EU MDR)
Ref 20063092
Identity
- Trade Name
- TruSight™ Oncology Comprehensive (EU) kit EUDAMED
- Device Name
- TruSight Oncology Comprehensive (EU) kit EUDAMED
- Model / Reference
- 20063092 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816270020620 EUDAMED
- Basic UDI-DI
- B-00816270020620 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
TruSight™ Oncology Comprehensive (EU) kit by Illumina, 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-00816270020620 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Illumina, Inc.
- EUDAMED SRN
- US-MF-000013476
- Authorised Representative
- Illumina Netherlands B.V. NL-AR-000012614
Sources (1)
- EUDAMED 22de4540-8a6e-494b-bbb0-ce9d46738ce3 61 fields · synced Jul 8, 2026