Profile: Heine USA Ltd. designs and manufactures diagnostic instruments. Our product includes otoscopes, ENT specialty instruments, pocket diagnostic lights, retinoscopes, hand-held slit lamps, binocular loupes, headlights, power sources, bulbs, fiber optic projectors, and diagnostic sets. The ENT speciality instruments include straight laryngeal mirror, curved laryngeal mirror, tongue blade holder, blade ejector, illuminator, and fiber optic nasal illuminator. Our alpha+® dermatoscope consists of adjustable focus & threaded connector. Our universal clip fits any spectacles & can be used by various examiners. Our Beta 200® ophthalmoscope consists of aspherical optics.

The company has ~20 employees and is ISO 9000, CE certified.

FDA Registration Number: 1000379039
US Agent: Greg Clark / Heine Usa Ltd
Phone: +1-(603)-842-6632  Fax: +1-(603)-742-7217  E-Mail:

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• AC-Powered Biomicroscope Slit Lamp (FDA Code: HJO / 886.1850) An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

• AC-Powered Medical Examination Device (FDA Code: KZF / 880.6320) An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

• AC-Powered Operating Headlamp (FDA Code: HPQ / 886.4335) An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

• AC-Powered Ophthalmoscope (FDA Code: HLI / 886.1570) An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

• AC-Powered Retinoscope (FDA Code: HKL / 886.1780) A retinoscope is an AC-powered or battery-powered device intended to measure the refraction of the eye by illuminating the retina and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent rays.

• AC-Powered Transilluminator (FDA Code: HJM / 886.1945) A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.

• Adjustable Bone Holding Forceps

• Adjustable Sphygmomanometer

• Adson 1 x 2 Teeth Tissue Forceps

• Adson-Graefe Tissue Forceps

• Adult Muscle Forceps

• Adult Tongue Depressor (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• All-Purpose Foreign Body Forceps

• Alligator Forceps

• Aneroid Sphygmomanometer

• Angled Micro Capsulorhexis Forceps

• Angled Micro Tying Forceps

• Angled tying utility Forceps

• Anoscope and Accessories (FDA Code: FER / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Anterior chamber utility Forceps

• Battery-Operated Operating Headlamp (FDA Code: HPP / 886.4335)

• Battery-Powered Medical Examination Light (FDA Code: KYT / 880.6350) A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

• Battery-Powered Ophthalmoscope (FDA Code: HLJ / 886.1570)

• Battery-Powered Retinoscope (FDA Code: HKM / 886.1780)

• Battery-Powered Transilluminator (FDA Code: HJN / 886.1945)

• Binocular Indirect Ophthalmoscopes

• Biopsy Forceps, Internal Jugular Approach 7

• BiPolar Bayonet Forceps

• Bipolar Forceps, Handswitching

• Blood pressure Cuffs (FDA Code: DXQ / 870.1120) A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

• Bone Holding and Plate Holding Forceps

• Clinical Mercury Thermometers (FDA Code: FLK / 880.2920) A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.

• Coin Operated Sphygmomanometer

• Compact Handheld pH Meter

• Corneal fixation Forceps

• Corneal Suturing Forceps

• Corneal Utility Forceps

• Corneoscleral Suturing Forceps

• Cross-action cilia Forceps

• Cup Biopsy Forceps

• Curved Haemostatic Mosquito Forceps

• Curved Intraocular Lens Forceps

• Curved Iris Forceps

• Curved Jeweler's Forceps

• Cushing Bayonet Forceps

• Dental Forceps

• Diagnostic Condensing Lens (FDA Code: HJL / 886.1380) A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.

• Diagnostic/Surgical Loupe (FDA Code: FSP / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Diagnostics Lamps

• Digital Handheld pH Meters