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FAST PML/RARα (RARA) Translocation, Dual Fusion Probe
EUDAMEDClass C (EU MDR)
Ref CE-LPH 064Ref CE-LPH 064-S
Identity
- Trade Name
- FAST PML/RARα (RARA) Translocation, Dual Fusion Probe EUDAMED
- Device Name
- FAST PML/RARα (RARA) Translocation, Dual Fusion Probe EUDAMED
- Model / Reference
- CE-LPH 064 EUDAMEDCE-LPH 064-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055844906600 EUDAMED05055844906617 EUDAMED
- Basic UDI-DI
- 50558449LPH064JR EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER 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
FAST PML/RARα (RARA) 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 | 50558449LPH064JR | 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 (2)
- EUDAMED d55b6229-ecbb-453c-b636-372b496f1f04 61 fields · synced Jul 28, 2026
- EUDAMED f9673755-9831-4f56-a3d0-ee9df4967d00 61 fields · synced May 17, 2026