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Actizyme

EUDAMED

Class I (EU MDR)

Ref FM0343Ref FM0171Ref FM1322Ref FM0303

by Mondial Srl

Identity

Trade Name
Actizyme EUDAMED
Device Name
DISPOSITIVI MEDICI DETERGENTI EUDAMED
Model / Reference
FM0343 EUDAMED
FM0171 EUDAMED
FM1322 EUDAMED
FM0303 EUDAMED

Identifiers

Primary DI / UDI-DI
08032804643727 EUDAMED
08032804643703 EUDAMED
08032804645639 EUDAMED
08032804644991 EUDAMED
Basic UDI-DI
803280464F19CZ EUDAMED
EMDN Code
D0899 DETERGENTS FOR MEDICAL DEVICES - OTHER EUDAMED
D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES EUDAMED
D0801,V0799 EUDAMED
V0799 PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED

Classification

Device Class
Class I 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

Actizyme by Mondial Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Mondial Srl
EUDAMED SRN
IT-MF-000022978

Sources (5)

  • EUDAMED 7fbfb91c-97ee-43a6-a6ef-18cc791d4ff6 61 fields · synced Oct 7, 2026
  • EUDAMED 18180c9c-fa59-4a2c-9c6b-95f69e12f81d 61 fields · synced Jun 20, 2026
  • EUDAMED 1f7f49ca-b875-4b00-94b1-94501f2d5c3e 61 fields · synced Jul 8, 2026
  • EUDAMED 84754011-907b-4393-9576-15837b9652db 61 fields · synced Jul 27, 2026
  • EUDAMED b8459bd8-4bac-4130-8f4e-19e7af390a87 61 fields · synced Jul 28, 2026