Data / Medical devices / Weights, Eyelid, External
Weights, Eyelid, External (MML): 12 FDA-registered makers in 8 countries
12 establishments in 8 countries are registered with the FDA to make Weights, Eyelid, External (product code MML, Class 2, 21 CFR 886.5700). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on June 6, 2017, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MML
- Device class
- 2
- Regulation
- 886.5700
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| Germany | 3 |
| United States | 2 |
| United Kingdom | 2 |
| Canada | 1 |
| India | 1 |
| Switzerland | 1 |
| France | 1 |
| Mauritius | 1 |
Makers of Weights, Eyelid, External
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Meddev Corp. | Sunnyvale, CA, United States | Manufacturer | 3 | August 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| Heinz Kurz GMBH Medizintechnik | DUSSLINGEN Baden-Wurttemberg, Germany | Manufacturer | 2 | May 2, 2001 | 0 | 0 | 0 | api.fda.gov |
| Katena Products, Inc. | Randolph, NJ, United States | Repackager or relabeler, Specification developer | 2 | April 12, 1999 | 0 | 0 | 0 | api.fda.gov |
| Altomed Ltd. | Boldon Colliery South Tyneside, United Kingdom | Manufacturer | 1 | June 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Labtician Ophthalmics, Inc. | OAKVILLE Ontario, Canada | Manufacturer | 1 | January 8, 1999 | 0 | 0 | 0 | api.fda.gov |
| Spiggle & Theis Medizintechnik GMBH | OVERATH North Rhine-Westphalia, Germany | Manufacturer, Specification developer | 1 | January 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| Akriti Ophthalmic Private Limited | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cendres+metaux SA | Biel/Bienne Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fci SAS | BESANCON Doubs, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fci Sud | MAPOU LECLEZIO GOODLANDS Riviere du Rempart, Mauritius | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wesley Coe (cambridge) Ltd | ELY, CAMBS Cambridgeshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 6, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.