JM Optical supplies eyewear with CE documentation, FDA registration and EN ISO test reports, and we publish the actual documents rather than describing them in general terms. Certificates on this page are issued to our Wenzhou production facility, Wenzhou Dilicn Optical Co., Ltd, and SHANGHAI JM OPTICAL CO., LTD is named as the exporter on all shipping documents, so the company name on your invoice, packing list and certificate will match.
Each certificate below covers specific models or lens types. When you place an order we send the report that matches the exact model and lens you are buying, because a report for one lens specification does not cover another.
What documents you receive with an order
- CE documentation review and EU declaration of conformity support (MDR 2017/745)
- FDA establishment registration and medical device listing numbers
- FDA impact resistance certificate and drop ball test record (21 CFR 801.410)
- EN ISO 12870 frame test report covering the model you order
- Lens test reports for UV400, CR39, TAC polarized and blue light lenses
- Product and user information sheet for sunglasses, for EU retail packaging
Documents are issued per shipment, in PDF, with the invoice number referenced on the certificate. If your customs broker or notified body needs a specific format, tell us before production rather than after the goods ship.
CE marking and EU MDR documentation
Our CE documentation review was carried out by ICR Polska under reference ICR Polska/DR/HS221009, covering optical frames in models J, H, K and JA as Class I devices under Medical Devices Regulation (EU) 2017/745. The technical documentation (TMZ/22101741809) was prepared by Shanghai Global Testing Services and reviewed on 21 October 2022, with the review valid until 20 October 2027.
One point worth stating plainly: this is a voluntary documentation review, not a notified body certificate. Class I eyewear does not require notified body involvement, and the manufacturer remains responsible for the CE marking process. If your compliance team needs a notified body opinion for a specific market, that has to be arranged separately, and we will tell you so before you commit to an order rather than let you assume otherwise.
FDA registration and impact resistance
Our facility is registered with the US Food and Drug Administration under registration number 3015276099, with medical device listing D345490. Both numbers can be checked directly in the FDA databases, which is the fastest way for a US buyer to verify a supplier before placing a first order.
Impact resistance is tested under 21 CFR 801.410 using drop ball testing with normal sampling under MIL-STD-105. The most recent inspection record, certificate number 505 dated 22 July 2025, covers 612 pieces with 80 lenses sampled and zero breakage, and lists the style numbers tested on the same sheet.
EN ISO 12870 spectacle frame testing
Frames are tested to EN ISO 12870:2018, the European standard for spectacle frames. The report covers construction and edge safety, dimensional tolerances, dimensional stability after heating, bridge deformation, endurance of the front and temples, lens retention, perspiration resistance, and optional optical radiation and flammability checks.
The test results are reported item by item with measured values against the standard’s limits, not just a pass stamp, so your own quality team can see what was actually measured on the sample they will be shipped.
Lens testing: UV400, CR39, TAC and blue light
Sunglass lenses are certified against ANSI Z80.3:2018, EN ISO 12312-1:2022, AS/NZS 1067.1 and GB 39552.1. The reports record luminous transmittance, filter category, colour coordinates, signal light transmittance and UV transmittance, which is what customs and market surveillance authorities ask for.
Our CR39 sunglass lens sample CR39-B201 was tested on 26 June 2025 and passes all four standards with filter category 2 and 21.83% luminous transmittance. The TAC-B22 polarized lens report shows 22.30% transmittance and passes ANSI Z80.3:2018. Both are UV400.
Blue light lenses are documented differently, because blue light blocking is a regulated claim in several markets. Our anti-blue-ray lens report dated 18 December 2025 tests the lens against EN ISO 12312-1:2022, AS/NZS 1067.1 and ANSI Z80.3, and publishes the full transmittance spectrum so the blocking range can be read directly instead of taken from a marketing percentage.
Downloadable lens and product documents
What we do not claim
We do not publish certificates for products we do not make, and we do not reuse one model’s report for another. If a buyer needs a standard we have not tested yet, such as a specific national standard or a sports eyewear impact class, we will say so and quote the testing cost and lead time instead of sending an unrelated document.
If you need to understand which standard applies to your market before ordering, our guide to CE, FDA and ISO 12870 requirements explains the difference between marking, registration and testing, and our sampling and testing guide covers what happens to your order before shipment.
Request documents for a specific model
Tell us the model number or the style you are considering, plus the destination market, and we will send the matching certificate set and confirm what is covered. For markets with extra requirements we will flag them at quotation stage rather than at shipment.