Occluder, handheld, with pinhole

GENERAL DESCRIPTION
Handheld occluder with an opaque cover on one end and a pinhole on the other end, used in vision testing to isolate one eye and support visual assessment.

Minimum Order Quantity (MOQ): 25

INTENDED USE
Used to cover one eye while assessing the visual acuity, refraction, and alignment of the other eye. The pinhole is used to determine whether reduced vision is due to uncorrected refractive error. Suitable for use in community and primary healthcare screenings, and in comprehensive eye examinations by optometrists and ophthalmologists.

TECHNICAL SPECIFICATIONS
Handheld occluder with opaque cover on one end and a single pinhole on the other end.
Circular end diameter: 25mm.
Pinhole diameter: 1.2mm.
Colour: black.
Material: durable, easy-to-clean plastic.

ESTIMATED LIFE SPAN
8 years.

ENVIRONMENTAL CONDITIONS
Operating conditions: 10 to 40C/ 90% relative humidity
Storage conditions: 0 to 50C/ 90% relative humidity

QUALITY MANAGEMENT SYSTEM
Manufacturer is certified to ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes.
Supplier is certified to ISO 9001 Quality management systems – Requirements.

REGULATION & CONFORMITY REQUIREMENTS
CE-marked Class I medical device, self-declared under EU MDR 2017/745.

NOMENCLATURE
GMDN©: 37337
EMDN: Y210336