Regulatory

Source-Ray, Inc. is a fully certified ISO 13485 and FDA Registered facility that manufactures 100% in the USA. Many of our products are currently certified with the FDA and listed with Underwriters Laboratory. Custom OEM products can be certified to a variety of standards as requested by customer. Please contact us for additional information if you cannot find what you are looking for.

FDA Documents

Establishment Registration
Content:
510(k)_UC-5000_K163063
Content:
510K PXS-710D
Content:
510K PowerMax 1260
Content:
510K SR-130
Content:
510K SR-130-D
Content:
510K SR-115
Content:
510K PXS-810
Content:
Acc PowerMax 1260
Content:
Acc SR-130
Content:
Acc SR-130D
Content:
Acc SR-115
Content:
Acc SB-125-7K-P
Content:
Acc SR-100-3KF
Content:
Acc PXS-710D
Content:
Health Canada License 020415

UL Mark Information

UL NOA SR-130
Content:
UL NOA SB-75-150
Content:
UL NOA SB-60-333
Content:
UL NOA SB-80-250
Content:
UL NOA SB-80-500
Content:
UL NOA SB-80-500-DI
Content:
UL NOA SB-60-50

ISO Certification

Content:
ISO 13485-2016
Content:
ISO 13485-2016 (Canada)