Identity
- Device Name
- MONOCLEAN TYPE 18 EUDAMED
- Model / Reference
- MONO 18 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056254790077 EUDAMED
- Basic UDI-DI
- 805625479BAVLR EUDAMED
- Direct Marketing DI
- 08056254790077 EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - 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
Monoclean Type 18 by Pharma Eec 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805625479BAVLR | Class I | Active |
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Manufacturer
- Manufacturer
- Pharma Eec Srl
- EUDAMED SRN
- IT-MF-000037561
Sources (1)
- EUDAMED f3e482f6-13ec-4dff-9e1d-6b85ee48dfdf 61 fields · synced Jul 10, 2026