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Dentalzym5
EUDAMEDClass I (EU MDR)
Ref DENTALZYM5Model Detergente
by Smeg S.p.A.
Identity
- Trade Name
- DENTALZYM5 EUDAMED
- Model / Reference
- Detergente EUDAMEDDENTALZYM5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08017709232856 EUDAMED
- Basic UDI-DI
- 8017709DETER-2SN EUDAMED
- EMDN Code
- D0801 ENZYMATIC DETERGENTS FOR MEDICAL DEVICES 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
Category: Medical device disinfection agent
Dentalzym5 by Smeg S.p.A. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Medical device disinfection agent.
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- Coltene Biosonic UC40 — Topdental (Products) Ltd · Class I
- Enzymatic Detergent — QUADRALENE LTD · Class I
- Enzym Med Wipes — Laboratorium Dr. Deppe GmbH · Class I
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 | 8017709DETER-2SN | Class I | Active |
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Manufacturer
- Manufacturer
- Smeg S.p.A.
- EUDAMED SRN
- IT-MF-000019585
Sources (1)
- EUDAMED 985743c5-590f-4565-ac01-a43cd43b37fa 61 fields · synced Jun 18, 2026