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MSI digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref "Model: MS01-Q24; Specification: 24 Tests Model: MS01-Y24; Specification: 24 Tests"Model MS01-Q24,MS01-Y24Ref 12690-2Model MS01-Y24Model MS01-Q24
Identity
- Trade Name
- MSI digital PCR detection kit EUDAMED
- Device Name
- MSI digital PCR detection kit EUDAMED
- Model / Reference
- MS01-Q24,MS01-Y24 EUDAMED"Model: MS01-Q24; Specification: 24 Tests Model: MS01-Y24; Specification: 24 Tests" EUDAMEDMS01-Y24 EUDAMED12690-2 EUDAMEDMS01-Q24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626421 EUDAMED06974689627206 EUDAMED
- Basic UDI-DI
- B-06974689626421 EUDAMEDB-06974689627206 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMEDW01060214 COLORECTAL CANCER (MSI-H / DMMR) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMEDAustria 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
MSI digital PCR detection kit by TargetingOne Technology (Beijing) Corporation — 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-06974689626421 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED 2070f002-816f-4934-950e-e2b475f39850 61 fields · synced Jul 21, 2026
- EUDAMED 2070f002-816f-4934-950e-e2b475f39850-1 61 fields · synced Jun 9, 2026
- EUDAMED 8e1b3255-b17b-49b1-b313-f75ffe07b124 61 fields · synced Jul 9, 2026
- EUDAMED 30dac458-6498-46d1-a14e-91d5effa2d3d-1 61 fields · synced Jul 21, 2026