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Mingwei

FDA UDI

Class I (US FDA UDI)

by MingWei Medical Technology(Suzhou)Co., LTD

Identity

Trade Name
Mingwei FDA UDI
Generic Name
X-ray tube housing assembly, diagnostic FDA UDI
Device Name
A metallic case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. FDA UDI
Model / Reference
MWHX7220B FDA UDI
Description
A metallic case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. FDA UDI

Identifiers

Primary DI / UDI-DI
26973915530161 FDA UDI
FDA Product Code
ITY FDA UDI
GMDN Term
X-ray tube housing assembly, diagnostic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1760 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: X-ray tube housing assembly, diagnostic

Mingwei by MingWei Medical Technology(Suzhou)Co., LTD — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as X-ray tube housing assembly, diagnostic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI a41b591c-cf38-4043-96a6-9244a500c5d1 33 fields · synced Jun 1, 2026