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Medical CT X-ray tube assembly

FDA UDI

Class I (US FDA UDI)

by Beijing Smartbeam Medical Devices Co., LTD

Identity

Trade Name
Medical CT X-ray tube assembly FDA UDI
Generic Name
X-ray system tube FDA UDI
Model / Reference
ZS302B/H580B FDA UDI

Identifiers

Primary DI / UDI-DI
16977943360014 FDA UDI
FDA Product Code
ITY FDA UDI
GMDN Term
X-ray system tube 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: X-ray system tube

Medical CT X-ray tube assembly by Beijing Smartbeam Medical Devices Co., LTD — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as X-ray system tube.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beijing Smartbeam Medical Devices Co., LTD

Sources (1)

  • FDA UDI 85b80521-aaec-4d7c-8b01-05a1f5e798a1 32 fields · synced May 30, 2026