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ARX CLEAN evo
EUDAMEDClass IIb (EU MDR)
Ref M7E200500, M7E200520, M7E200510Model Washer-disinfectors employing thermal disinfection and/or ultrasound, for medical purpose
by CEFLA s.c.
Identity
- Trade Name
- ARX CLEAN evo EUDAMED
- Model / Reference
- Washer-disinfectors employing thermal disinfection and/or ultrasound, for medical purpose EUDAMEDM7E200500, M7E200520, M7E200510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837936671 EUDAMED
- Basic UDI-DI
- 803383793STUWASHDB0015F EUDAMED
- Direct Marketing DI
- 08033837936671 EUDAMED
- EMDN Code
- Z12011301 CLEANING AND DISINFECTION EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Surgical utensil washer/disinfector
ARX CLEAN evo by CEFLA s.c. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803383793STUWASHDB0015F | Class IIb | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
- EUDAMED SRN
- IT-MF-000009228
Sources (2)
- EUDAMED 638924b1-525b-4c09-a38d-654c87804139 61 fields · synced Jul 8, 2026
- EUDAMED 638924b1-525b-4c09-a38d-654c87804139-1 61 fields · synced Jun 10, 2026