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BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe
EUDAMEDClass C (EU MDR)
Ref CE-LPH 038
Identity
- Trade Name
- BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe EUDAMED
- Device Name
- BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe EUDAMED
- Model / Reference
- CE-LPH 038 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055844906501 EUDAMED
- Basic UDI-DI
- 50558449LPH038JQ EUDAMED
- EMDN Code
- W01060208 T (9;22) EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
New Device
No
EUDAMED
BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe by Cytocell Limited — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 50558449LPH038JQ | Class C | Active |
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Manufacturer
- Manufacturer
- Cytocell Limited
- EUDAMED SRN
- GB-MF-000016893
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (1)
- EUDAMED 7e27d8e0-9006-4c68-b9f9-f3dc756c8d96 61 fields · synced Jul 19, 2026