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Colorectal cancer methylation digital PCR panel
EUDAMEDClass IVD General (EU MDR)
Ref "Model: CM01-Q24; Specification: 24 Tests Model: CM01-Y24; Specification: 24 Tests"Model CM01-Q24、CM01-Y24Ref 12693-1Model CM01-Q24Ref 12693-2Model CM01-Y24
Identity
- Trade Name
- Colorectal cancer methylation digital PCR panel EUDAMED
- Device Name
- Colorectal cancer methylation digital PCR panel EUDAMED
- Model / Reference
- CM01-Q24、CM01-Y24 EUDAMED"Model: CM01-Q24; Specification: 24 Tests Model: CM01-Y24; Specification: 24 Tests" EUDAMEDCM01-Q24 EUDAMED12693-1 EUDAMEDCM01-Y24 EUDAMED12693-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626025 EUDAMED06974689627015 EUDAMED
- Basic UDI-DI
- B-06974689626025 EUDAMEDB-06974689627015 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMEDW01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Colorectal cancer methylation digital PCR panel by TargetingOne Technology (Beijing) Corporation — 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-06974689626025 | 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 (5)
- EUDAMED 647b8053-a4a1-4bcf-bb24-180e95a99f4e 61 fields · synced Jul 17, 2026
- EUDAMED 647b8053-a4a1-4bcf-bb24-180e95a99f4e-1 61 fields · synced Jun 10, 2026
- EUDAMED 647b8053-a4a1-4bcf-bb24-180e95a99f4e-2 61 fields · synced Jun 10, 2026
- EUDAMED a92c889c-f1aa-4edc-b4d3-5e8913ecb03b 61 fields · synced Jul 10, 2026
- EUDAMED c4b470f2-e630-427f-9b83-6add455bcccb 61 fields · synced Jul 17, 2026