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Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence P…
EUDAMEDClass IVD General (EU MDR)
Ref QP02004802
Identity
- Trade Name
- Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence Probing) EUDAMED
- Device Name
- Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence Probing) EUDAMED
- Model / Reference
- QP02004802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975970650033 EUDAMED
- Basic UDI-DI
- B-06975970650033 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence P… by Singlera Genomics (jiangsu) Ltd. — Class IVD General — IVDD — listed in…
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-06975970650033 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Singlera Genomics (jiangsu) Ltd.
- EUDAMED SRN
- CN-MF-000033428
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED e6a1b648-1253-4066-94d3-a28ec8c07753 61 fields · synced Jun 19, 2026
- EUDAMED 0f0f339e-54af-4b32-88fe-b9abcdbd1498 61 fields · synced Jun 19, 2026