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Oncology Multi-Gene Variant Assay
EUDAMEDClass IVD General (EU MDR)
Ref KB5002048
Identity
- Trade Name
- Oncology Multi-Gene Variant Assay EUDAMED
- Device Name
- Oncology Multi-Gene Variant Assay EUDAMED
- Model / Reference
- KB5002048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975352996025 EUDAMED
- Basic UDI-DI
- B-06975352996025 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Portugal 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 Multi-Gene Variant Assay by Suzhou GenePlus Biomedical Engineering Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06975352996025 | 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 e9ad1692-e3bf-4565-abad-bc216503080a 61 fields · synced Jul 16, 2026