Identity
- Trade Name
- EVOBITE FDA UDI
- Generic Name
- Dental guided surgery registration/navigation spatial marker FDA UDI
- Device Name
- EVOBITE EUDAMED
- Model / Reference
- SPA00200 EUDAMEDEVOFLAT FDA UDI
Identifiers
- Catalog Number
- SPA00200 FDA UDI
- Primary DI / UDI-DI
- 08050038830065 EUDAMEDFDA UDI
- Basic UDI-DI
- 805003883EVOBITEK4 EUDAMED
- FDA Product Code
- EHY FDA UDI
- EMDN Code
- Z119085 VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Dental guided surgery registration/navigation spatial marker FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6880 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Evobite by 3diemme Srl — Class I — 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 | 805003883EVOBITEK4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- 3DIEMME srl
- EUDAMED SRN
- IT-MF-000016005
Sources (2)
- EUDAMED 035b3250-76e5-4f85-9ca2-c41b0e50d2dd 61 fields · synced Oct 6, 2026
- FDA UDI 8a55b917-7d2d-49e8-8070-e0ebe6271d1a 33 fields · synced May 30, 2026