Data / Medical devices / Drape, Patient, Ophthalmic
Drape, Patient, Ophthalmic (HMT): 31 FDA-registered makers in 7 countries
31 establishments in 7 countries are registered with the FDA to make Drape, Patient, Ophthalmic (product code HMT, Class 2, 21 CFR 878.4370). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on February 14, 1995, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HMT
- Device class
- 2
- Regulation
- 878.4370
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 11 |
| Vietnam | 7 |
| China | 5 |
| India | 4 |
| Dominican Republic | 2 |
| United Kingdom | 1 |
| Mexico | 1 |
Makers of Drape, Patient, Ophthalmic
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 |
|---|---|---|---|---|---|---|---|---|
| Atlanta Healthcare Services | Lawrenceville, GA, United States | Repackager or relabeler, Specification developer | 1 | February 13, 1986 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Fort Worth, TX, United States | Specification developer | 1 | April 6, 1983 | 0 | 1 | 0 | api.fda.gov |
| Alcon Research, LLC | Houston, TX, United States | Manufacturer | 1 | April 6, 1983 | 0 | 0 | 0 | api.fda.gov |
| Akriti Ophthalmic Private Limited | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health D.R. 203 Ii Ltd | Santo Domingo, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Daemyung Chemical Co., Ltd (vietnam) | An Phuoc Commune Dong Nai, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foothills Industries, Inc. | Marion, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Global Resources (vietnam) Group Limited Company | Hai Phong City, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gri Medical & Electronic Technology Co., Ltd. | JIAXING Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gri Medical & Electronic Technology Co., Ltd. | Wuhu Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hanh Minh Manufacturing Trading Company Limited | Bien Hoa Dong Nai, Vietnam | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haywood Vocational Opportunities Inc. | Waynesville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imentum Medical LLC | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Medplus Non-Woven Manufacturer Co.,ltd. | Siyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jilin Test Bio-Electron Co.,ltd | Changchun Jilin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marble Medical, Inc. | Tallahassee, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Dominicana, S.A.S. | La Romana, Dominican Republic | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical LLC | Alpharetta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nuline Medical | Patna South Ayrshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation | Dien Ban Bac Ward Da Nang, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quiroproductos de Cuauhtemoc S. De R.L. de C.V. | Cuauhtemoc Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Dochem Industries Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stevimed Medical Joint Stock Company | Can Giuoc Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgimed Devices | AHMEDABAD Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vien Phat Import Export Service Trading Joint Stock Company | Ben Thanh Ward Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VT Production Medical Materials Production Corporation | Can Giuoc Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Weslacova | North Wilkesboro, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 14, 1995. 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.