Identity
- Trade Name
- XR INSTRUMENT EUDAMED
- Device Name
- DISPOSITIVI MEDICI DETERGENTI EUDAMED
- Model / Reference
- FM1282 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08032804645158 EUDAMED
- Basic UDI-DI
- 803280464F19CZ EUDAMED
- EMDN Code
- D0899 DETERGENTS FOR MEDICAL DEVICES - 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
Xr Instrument 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803280464F19CZ | Class I | Active |
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Manufacturer
- Manufacturer
- Mondial Srl
- EUDAMED SRN
- IT-MF-000022978
Sources (1)
- EUDAMED 51c83137-ce30-4b33-a12a-ca56a1379afc 61 fields · synced Oct 6, 2026