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HSChapter 90
U.S. imports of other ophthalmic instruments, appliances & parts (HS 901850) totaled $47.0M in April 2026, traded with 45 countries.
Last updated: April 2026 dataOphthalmic instruments not elsewhere specified — including diagnostic, surgical, and measurement devices used in eye care — are regulated as medical devices by the FDA under 21 CFR, requiring registration and premarket clearance or approval before US entry. The entire heading consolidates under a single 10-digit tariff line (9018500000), so classification disputes typically hinge on whether a device is truly ophthalmic or falls under a more specific heading elsewhere in Chapter 90. Germany leads US supply, with Mexico and Switzerland also significant sources, reflecting the concentration of precision optical manufacturing in those markets.
AI-written summary of the official U.S. Census Bureau trade figures on this page — verify before relying on it.
Classification turns on whether the instrument is described by a more specific heading elsewhere in Chapter 90 (e.g., lasers under 9013, or spectacles under 9004). Only devices not captured by those more specific provisions fall into 901850 as a residual 'NESOI' heading. Consulting a licensed customs broker and reviewing CBP binding ruling precedents is advisable for borderline products.
Ophthalmic instruments are regulated as medical devices by FDA's Center for Devices and Radiological Health (CDRH). Importers must ensure the foreign manufacturer is registered with FDA, the device is listed, and any required 510(k) clearance or PMA approval is in place before the shipment arrives at the US port of entry.
| Country | Imports | Exports | Balance |
|---|---|---|---|
| BELGIUM | -- | $13.3M | +$13.3M |
| NETHERLANDS | $1.6M | $11.6M | +$10.0M |
| CHINA | $2.1M | $10.8M | +$8.7M |
| GERMANY | $8.2M | $4.6M | -$3.6M |
| MEXICO | $5.3M | $5.5M | +$224K |
Monthly import values over time
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