Identity
- Trade Name
- Oncology HRD Assay (M) EUDAMED
- Device Name
- Oncology HRD Assay (M) EUDAMED
- Model / Reference
- 115021301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975352996117 EUDAMED
- Basic UDI-DI
- B-06975352996117 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece 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
Oncology HRD Assay (M) by Suzhou GenePlus Biomedical Engineering Co., Ltd. — 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-06975352996117 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Suzhou GenePlus Biomedical Engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000035774
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 96928251-5263-4c6d-a2ff-b82b937aed38 61 fields · synced Jun 17, 2026