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RealGUIDE
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref REALGUIDE CAD+Model RealGUIDE
by 3DIEMME srl
Identity
- Trade Name
- 3DIEMME RealGUIDE FDA UDI
- Generic Name
- CAD/CAM software FDA UDI
- Device Name
- RealGUIDE EUDAMEDFull integrated planning, guide design and prosthesis modelling FDA UDI
- Model / Reference
- RealGUIDE EUDAMEDREALGUIDE CAD+ EUDAMEDFDA UDI
- Description
- Full integrated planning, guide design and prosthesis modelling FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08050038830058 EUDAMEDFDA UDI
- Basic UDI-DI
- 8050038833DM700PP EUDAMED
- 510(k) Number
- K173041 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- CAD/CAM software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
RealGUIDE by 3diemme Srl — 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 | 8050038833DM700PP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- 3DIEMME srl
- EUDAMED SRN
- IT-MF-000016005
Sources (2)
- EUDAMED fe700921-acc5-4d9c-8eeb-67bf10c3b2db 61 fields · synced Oct 6, 2026
- FDA UDI 07bf54de-e878-4828-9342-c47605c20175 35 fields · synced May 30, 2026