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Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR)
EUDAMEDClass IVD General (EU MDR)
Ref HWTS-GE010
Identity
- Trade Name
- Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR) EUDAMED
- Device Name
- Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR) EUDAMED
- Model / Reference
- HWTS-GE010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-0000128071500B3PT EUDAMED
- Basic UDI-DI
- B-0000128071500B3PT EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER 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
Human BCR-ABL Fusion Gene Mutation Detection Kit (Fluorescence PCR) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD — listed in…
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-0000128071500B3PT | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000012807
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3edc7a29-2c4b-433a-8280-7c0a7db3fe2a 61 fields · synced Jun 18, 2026