Identity
- Trade Name
- EVI1 (MECOM) Breakapart Probe EUDAMED
- Device Name
- EVI1 (MECOM) Breakapart Probe EUDAMED
- Model / Reference
- CE-LPH 036-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055844906495 EUDAMED
- Basic UDI-DI
- 50558449LPH036JL 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
EVI1 (MECOM) Breakapart 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 | 50558449LPH036JL | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cytocell Limited
- EUDAMED SRN
- GB-MF-000016893
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (1)
- EUDAMED bf8a83e5-e7c2-4a47-9988-d03306f22a46 61 fields · synced Jul 9, 2026