Identity
- Trade Name
- coDiagnostiX FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging system workstation FDA UDI
- Device Name
- coDiagnostiX EUDAMEDDental surgery treatment planning software FDA UDI
- Model / Reference
- CDX-001-MD EUDAMED10 FDA UDI
- Description
- Dental surgery treatment planning software FDA UDI
Identifiers
- Primary DI / UDI-DI
- D835CODX1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D835CODXDT EUDAMED
- Direct Marketing DI
- D835CODX1 EUDAMED
- FDA Product Code
- LLZ FDA UDIDZJ FDA UDI
- EMDN Code
- Z11069005 DIAGNOSTIC IMAGING WORKSTATIONS EUDAMED
- GMDN Term
- Diagnostic x-ray digital imaging system workstation FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI872.4120 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tissue specimen x-ray system IVD
coDiagnostiX by Dental Wings GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193301 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++D835CODXDT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dental Wings GmbH
- EUDAMED SRN
- DE-MF-000006867
Sources (3)
- EUDAMED 664ce0e6-5d32-4a46-bd98-f6316b86f98a 61 fields · synced Aug 1, 2026
- FDA UDI ac3a6117-0d8b-4a10-a84e-69b15af5d97c 35 fields · synced May 29, 2026
- FDA 510(k) K193301 1 fields · synced May 18, 2026