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Magnum Hyperone
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 41420131AModel Magnum Hyperone
Identity
- Trade Name
- Magnum Hyperone EUDAMEDFDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- MAGNUM HYPERONE - DISC PLAIN Ø98.5x22mm - Box1 - LM - MD FDA UDI
- Model / Reference
- Magnum Hyperone EUDAMED41420131A EUDAMED1 FDA UDI
- Description
- MAGNUM HYPERONE - DISC PLAIN Ø98.5x22mm - Box1 - LM - MD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08050612204534 EUDAMEDFDA UDI
- Basic UDI-DI
- 80506122000000000000011TZ EUDAMED
- Direct Marketing DI
- 08050612204534 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
Category: Dental casting non-noble alloy
Magnum Hyperone by Mesa Italia S.r.l. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental casting non-noble alloy.
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- NOBILIUM — CMP INDUSTRIES LLC · Class II
- System Ti5-Blank 98, 5 x 25 mm — Adentatec GmbH Competence in Dental · Class II
- NIRANIUM — CMP INDUSTRIES LLC · Class II
- Matticraft 75+ — Cookson Precious Metals Ltd · Class IIa
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 fa6fbfb1-5dfd-4435-92f8-962070afaf5c 61 fields · synced Jul 10, 2026
- FDA UDI ea5f22d7-743c-4d44-82ed-e764ca3528fa 34 fields · synced May 30, 2026