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Microsatellite Instability (MSI) Dx Analysis Test
EUDAMEDClass IVD General (EU MDR)
Ref EU002A01Model 24 tests/kit
Identity
- Device Name
- Microsatellite Instability (MSI) Dx Analysis Test EUDAMED
- Model / Reference
- 24 tests/kit EUDAMEDEU002A01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975296640473 EUDAMED
- Basic UDI-DI
- B-06975296640473 EUDAMED
- EMDN Code
- W01060206 HNPCC 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
Microsatellite Instability (MSI) Dx Analysis Test by MEDx (Suzhou) Translational Medicine 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-06975296640473 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MEDx (Suzhou) Translational Medicine Co., Ltd.
- EUDAMED SRN
- CN-MF-000028603
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED e3ed0e92-32a0-4675-a467-968c77b1255a 61 fields · synced Oct 6, 2026