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CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe
EUDAMEDClass C (EU MDR)
Ref CE-LPH 022-SRef CE-LPH 022
Identity
- Trade Name
- CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe EUDAMED
- Device Name
- CBFß (CBFB)/MYH11 Translocation, Dual Fusion Probe EUDAMED
- Model / Reference
- CE-LPH 022-S EUDAMEDCE-LPH 022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055844923607 EUDAMED05055844906358 EUDAMED05055844906341 EUDAMED05055844923591 EUDAMED
- Basic UDI-DI
- 50558449LPH022J9 EUDAMED
- EMDN Code
- W01060211 INV (16) 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
CBFß (CBFB)/MYH11 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 | 50558449LPH022J9 | 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 (4)
- EUDAMED c9f1aee7-ca0a-468b-b2ef-3ad2f32e2335 61 fields · synced Jul 30, 2026
- EUDAMED 7ba0b59c-12ea-4fb7-948b-74289c40a527 61 fields · synced May 17, 2026
- EUDAMED 47a8a82f-e06e-4ab3-87f0-352b3d5a795c 61 fields · synced May 18, 2026
- EUDAMED f71e27e9-0b1c-44f5-9c5e-dc69e3f03317 61 fields · synced Jul 21, 2026