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Magnum Hyerone
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 41420179AModel Magnum Hyperone
Identity
- Trade Name
- Magnum Hyerone EUDAMEDiMill Ti FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- iMill Ti - DISC CUT Ø98.5x12mm - BoxC - LM - MD FDA UDI
- Model / Reference
- Magnum Hyperone EUDAMED41420179A EUDAMED1 FDA UDI
- Description
- iMill Ti - DISC CUT Ø98.5x12mm - BoxC - LM - MD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08050612205999 EUDAMEDFDA UDI
- Basic UDI-DI
- 80506122000000000000011TZ EUDAMED
- Direct Marketing DI
- 08050612205999 EUDAMED
- FDA Product Code
- EJH FDA UDI
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
- GMDN Term
- Dental casting non-noble alloy FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3710 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Magnum Hyerone by Mesa Italia S.r.l. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 80506122000000000000011TZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Mesa Italia S.r.l.
- EUDAMED SRN
- IT-MF-000029407
Sources (2)
- EUDAMED 3d865069-6f55-4288-8f62-c2a915bbaf7f 61 fields · synced Sep 17, 2026
- FDA UDI 8c7fcabf-dfac-461f-bb84-08c7a34a2a6c 34 fields · synced May 22, 2026