Identity
- Trade Name
- Oncotype® Sample Prep Kit EUDAMED
- Device Name
- Oncotype Sample Prep Kit EUDAMED
- Model / Reference
- 100422 EUDAMED100445 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00852867008053 EUDAMED00852867008060 EUDAMED
- Basic UDI-DI
- 0852867008100407DJ EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class A 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
Yes
EUDAMED
Oncotype® Sample Prep Kit by Genomic Health Inc. — 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 | 0852867008100407DJ | Class A | 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 21d7cb28-cc96-4702-89c2-ef9e5c814c68 61 fields · synced Aug 1, 2026
- EUDAMED 2e39614f-a8cf-4923-8748-90e8b0d2b696 61 fields · synced May 19, 2026