← Back to catalogue
Comprehensive Genomic Profiling Based MRD Detection Assay (M)
EUDAMEDClass IVD General (EU MDR)
Ref 106021302
Identity
- Trade Name
- Comprehensive Genomic Profiling Based MRD Detection Assay (M) EUDAMED
- Device Name
- Comprehensive Genomic Profiling Based MRD Detection Assay (M) EUDAMED
- Model / Reference
- 106021302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975352996155 EUDAMED
- Basic UDI-DI
- B-06975352996155 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
Comprehensive Genomic Profiling Based MRD Detection Assay (M) 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-06975352996155 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Suzhou GenePlus Biomedical Engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000035774
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 13b8bb66-42ce-47b3-94f3-9879c82a7ce0 61 fields · synced Jun 19, 2026