Identity
- Trade Name
- ZEESAN EUDAMEDBCR-ABL1 p190 Kit EUDAMED
- Device Name
- BCR-ABL1 p190 Kit EUDAMED
- Model / Reference
- 803317 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956299703204 EUDAMED
- Basic UDI-DI
- B-06956299703204 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
- Poland EUDAMEDItaly 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
Zeesan by Xiamen Zeesan Biotech Co., Ltd. — 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-06956299703204 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Xiamen Zeesan Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000013246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED e7e1c037-60aa-4148-8f2b-bc49828e1208 61 fields · synced Oct 6, 2026
- EUDAMED 763e61db-ed62-4641-9f46-e5d792df90bf 61 fields · synced Jul 16, 2026