With a 185-year history in Buffalo, Reichert designs and manufactures diagnostic instruments that help eye-care professionals test vision and identify conditions such as glaucoma. Now a business of AMETEK, the company continues that tradition from its 83,000-square-foot Depew facility, where it makes technologies including the Phoroptor and Tono-Pen. Reichert’s medical-device operation is ISO 13485:2016 and MDSAP certified and distributes through more than 150 distributors worldwide.
ISO 13485:2016 / EN ISO 13485:2016
MDSAP (ISO 13485:2016)
Directive 93/42/EEC on medical devices, Annex II excluding Section 4
Directive 93/42/EEC on medical devices, Annex V metrological requirements only
FDA Registered Establishment 1319721
Registration
GSA Certified Vendor V797P-2114D
Registration
CEMARKING
Quality certification
EUMEDICALDEVICEDIRECTIVE9342EEC
Quality certification
GSA
Quality certification
Gulden OphthalmicsSince 1938, Gulden Ophthalmics has built its identity as an American manufacturer focused on the specialized needs of eye-care professionals. Based in the Philadelphia area, the company develops and makes ophthalmic instruments and medical devices for learning institutions and clinical customers worldwide, while also taking on custom plastic work beyond eye care. Its ISO 13485:2016 certification covers the manufacture, service and distribution of ophthalmic instruments, ocular implants and conformers.ELKINS PARK, PA
Keeler LtdWith more than a century of optical expertise, Keeler Ltd designs and manufactures ophthalmic instruments for eye-care professionals, including binocular indirect ophthalmoscopes and diagnostic equipment. Founded in 1917 by Charles D. Keeler, the Windsor-based company still operates its main UK manufacturing facility while also assembling selected instruments and servicing North American customers locally in Pennsylvania. Its medical devices are certified to ISO 13485 and ISO 14001 standards, alongside MDSAP, UKCA and CE requirements.MALVERN, PA
VectorVision Ocular Health (DBA: VectorVision)Founded by vision scientist David W. Evans, Ph.D., VectorVision makes standardized vision-testing instruments for measuring visual function in eye-care practices and clinical research. Based in Greenville, Ohio, the company has spent 30 years developing patented systems such as the CSV-1000, CSV-2000 and ESV-3000, which automatically control testing luminance for consistent results. Its equipment is used in more than 60 countries, 5,000 eye-care clinics and more than 50 FDA clinical trials.GREENVILLE, OH
DGH Technology, IncSince 1982, DGH Technology has manufactured ophthalmic ultrasound diagnostic equipment for eye-care professionals, producing its devices on site at its Pennsylvania factory. The multigenerational family company has shipped more than 40,000 medical ultrasound devices worldwide and supports customers through a network of distributors in over 60 countries.EXTON, PA