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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
Stationary general-purpose fluoroscopic x-ray system, analogue FDA UDI
Model / Reference
Apollo FDA UDI

Identifiers

Primary DI / UDI-DI
08057737120015 FDA UDI
510(k) Number
K050190 FDA UDI
FDA Product Code
KPW FDA UDI
IXL FDA UDI
KXJ FDA UDI
GMDN Term
Stationary general-purpose fluoroscopic x-ray system, analogue FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1610 FDA UDI
892.1670 FDA UDI
892.1980 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: Stationary general-purpose fluoroscopic x-ray system, analogue

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 Stationary general-purpose fluoroscopic x-ray system, analogue.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Villa Sistemi Medicali Spa

Sources (1)

  • FDA UDI d981eda2-50da-4855-892a-0733a9c4a271 33 fields · synced May 30, 2026