← Back to catalogue

Villa Sistemi Medicali

FDA UDI

Class II (US FDA UDI)

by Villa Sistemi Medicali Spa

Identity

Trade Name
Villa Sistemi Medicali FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation FDA UDI
Model / Reference
DRF 4343 FL FDA UDI

Identifiers

Primary DI / UDI-DI
08057737122262 FDA UDI
510(k) Number
K080859 FDA UDI
FDA Product Code
MQB FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1680 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Diagnostic x-ray digital imaging system workstation

Villa Sistemi Medicali by Villa Sistemi Medicali Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation.

Cleared under the same submission

K080859 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Villa Sistemi Medicali Spa

Sources (1)

  • FDA UDI cfae1800-210b-416e-b9ef-b69de19de852 33 fields · synced May 30, 2026