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BCR ABL p210/p190 digital PCR one-tube quant test
EUDAMEDClass IVD General (EU MDR)
Ref 3.02.03.0001Model 24 Test
Identity
- Trade Name
- BCR ABL p210/p190 digital PCR one-tube quant test EUDAMED
- Device Name
- BCR ABL p210/p190 digital PCR one-tube quant test EUDAMED
- Model / Reference
- 24 Test EUDAMED3.02.03.0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975760470162 EUDAMED
- Basic UDI-DI
- B-06975760470162 EUDAMED
- EMDN Code
- W01060208 T (9;22) 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
BCR ABL p210/p190 digital PCR one-tube quant test by Suzhou Precigenome Ltd, Co; — 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-06975760470162 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Suzhou Precigenome Ltd, Co;
- EUDAMED SRN
- CN-MF-000024105
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED ddce8d7a-d723-4884-98de-2235a7a379db 61 fields · synced Jul 14, 2026