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iRay

FDA UDI

Class II (US FDA UDI)

by Iray Imaging Technology (Haining) Limited

Identity

Trade Name
iRay FDA UDI
Generic Name
Automatic-aperture-control diagnostic x-ray system collimator FDA UDI
Model / Reference
CRUX RF10 FDA UDI

Identifiers

Primary DI / UDI-DI
06975501940282 FDA UDI
FDA Product Code
IZW FDA UDI
GMDN Term
Automatic-aperture-control diagnostic x-ray system collimator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1610 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: Automatic-aperture-control diagnostic x-ray system collimator

iRay by Iray Imaging Technology (Haining) Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Automatic-aperture-control diagnostic x-ray system collimator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Iray Imaging Technology (Haining) Limited

Sources (1)

  • FDA UDI 81ec4bcc-12b8-4885-a399-8b4e87c9f4d6 32 fields · synced May 29, 2026