← Back to catalogue
BCR-ABL p190 digital PCR detection kit
EUDAMEDClass IVD General (EU MDR)
Ref "Model: BA02-Q32; Specification: 32 Tests Model: BA02-Y32; Specification: 32 Tests"Model BA02-Q32;BA02-Y32;Ref 12904-1Model BA02-Q32
Identity
- Trade Name
- BCR-ABL p190 digital PCR detection kit EUDAMED
- Device Name
- BCR-ABL p190 digital PCR detection kit EUDAMED
- Model / Reference
- BA02-Q32;BA02-Y32; EUDAMED"Model: BA02-Q32; Specification: 32 Tests Model: BA02-Y32; Specification: 32 Tests" EUDAMEDBA02-Q32 EUDAMED12904-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974689626070 EUDAMED
- Basic UDI-DI
- B-06974689626070 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMEDW0106010499 POLYMORPHISM TESTS - OTHER 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
BCR-ABL p190 digital PCR detection kit 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-06974689626070 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- TargetingOne Technology (Beijing) Corporation
- EUDAMED SRN
- CN-MF-000028247
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED b02e2cde-7840-4e48-8955-d7ebad1edb86 61 fields · synced Jun 20, 2026
- EUDAMED b02e2cde-7840-4e48-8955-d7ebad1edb86-1 61 fields · synced Jun 10, 2026
- EUDAMED b02e2cde-7840-4e48-8955-d7ebad1edb86-2 61 fields · synced Jun 10, 2026
- EUDAMED a237ee0a-b0cc-4176-8558-ad3269a3a73c 61 fields · synced Jun 20, 2026