Identity
- Trade Name
- Tele VD3 EUDAMEDVilla Sistemi Medicali FDA UDI
- Generic Name
- Thoracic public health screening x-ray system FDA UDI
- Device Name
- Tele VD3 EUDAMED
- Model / Reference
- 9778301110 EUDAMEDTele VD3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057737122514 EUDAMEDFDA UDI
- Basic UDI-DI
- 805773712FT1069D EUDAMED
- Direct Marketing DI
- 08057737122514 EUDAMED
- FDA Product Code
- IXY FDA UDI
- EMDN Code
- Z11030506 TELERADIOGRAPHS EUDAMED
- GMDN Term
- Thoracic public health screening x-ray system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1880 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
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
No
FDA UDI
Tele VD3 by Villa Sistemi Medicali S.p.a. — 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 | 805773712FT1069D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Villa Sistemi Medicali S.p.A.
- EUDAMED SRN
- IT-MF-000016860
Sources (2)
- EUDAMED e6195287-cb76-4e15-803b-99724f96aebc 61 fields · synced Jun 19, 2026
- FDA UDI 29d2fc88-e676-475a-8cef-d427d7f97e69 32 fields · synced May 30, 2026