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Oncotype DX Breast Recurrence Score® Kit
EUDAMEDClass C (EU MDR)
Ref 100441Ref 100421
Identity
- Trade Name
- Oncotype DX Breast Recurrence Score® Kit EUDAMED
- Device Name
- Oncotype DX Breast Recurrence Score® Test EUDAMED
- Model / Reference
- 100441 EUDAMED100421 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00852867008046 EUDAMED00852867008039 EUDAMED
- Basic UDI-DI
- 0852867008100406DG EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Oncotype DX Breast Recurrence Score® Kit by Genomic Health Inc. — Class C — 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 | 0852867008100406DG | Class C | Active |
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Manufacturer
- Manufacturer
- Genomic Health Inc.
- EUDAMED SRN
- US-MF-000018730
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 02fba4e6-81c7-4c87-aa0d-a25cd5eeed47 61 fields · synced Jul 21, 2026
- EUDAMED 2558df28-5632-4f48-9d1c-4315e91d90d3 61 fields · synced May 18, 2026