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Mont Blanc
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 12200XModel Surgical Contra-angle / handpiece & accessory
by anthogyr
Identity
- Trade Name
- Mont Blanc EUDAMEDAXIOM® FDA UDI
- Generic Name
- Dental power tool handpiece motorless component FDA UDI
- Device Name
- SURGICAL CONTRA-ANGLE FDA UDI
- Model / Reference
- Surgical Contra-angle / handpiece & accessory EUDAMED12200X EUDAMEDFDA UDI
- Description
- SURGICAL CONTRA-ANGLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663394011037 EUDAMEDFDA UDI
- Basic UDI-DI
- 36633940122QR EUDAMED
- FDA Product Code
- EGS FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dental power tool handpiece motorless component FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mont Blanc by anthogyr — 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 | 36633940122QR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- anthogyr
- EUDAMED SRN
- FR-MF-000000602
Sources (2)
- EUDAMED 37f600f0-14d3-432e-b641-520c7e11864c 61 fields · synced Oct 6, 2026
- FDA UDI c21d4c58-be38-4de2-badd-4d4cccc9b22c 33 fields · synced May 30, 2026