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Data / Medical devices / Drape, Urological, Disposable

Drape, Urological, Disposable (EYY): 25 FDA-registered makers in 6 countries

25 establishments in 6 countries are registered with the FDA to make Drape, Urological, Disposable (product code EYY, Class 2, 21 CFR 878.4370). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on May 14, 1985, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
EYY
Device class
2
Regulation
878.4370
Medical specialty
General, Plastic Surgery

Makers by country

CountryMakers
Vietnam7
United States7
Mexico4
Dominican Republic3
China3
India1

Makers of Drape, Urological, Disposable

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
3M Edumex, S.A De C.VCD. JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Bong Bach Tuyet Joint Stock CompanyHo Chi Minh, VietnamManufacturer0000api.fda.gov
Cardinal Health D.R. 203 Ii LtdSanto Domingo, Dominican RepublicManufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Daemyung Chemical Co., Ltd (vietnam)An Phuoc Commune Dong Nai, VietnamManufacturer0000api.fda.gov
Das Medical International, SRLLa Romana, Dominican RepublicContract manufacturer, Repackager or relabeler0000api.fda.gov
Endonest Medical Systems LLPPALGHAR Maharashtra, IndiaManufacturer0000api.fda.gov
Hanh Minh Manufacturing Trading Company LimitedBien Hoa Dong Nai, VietnamManufacturer, Repackager or relabeler0000api.fda.gov
Jiangsu Medplus Non-Woven Manufacturer Co.,ltd.Siyang Jiangsu, ChinaManufacturer0000api.fda.gov
K-Med Co., Ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Microtek Dominicana, S.A.S.La Romana, Dominican RepublicContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Microtek Medical LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Microtek Medical LLCNorthfield, IL, United StatesSpecification developer0000api.fda.gov
PROCEPT BioRobotics CorporationSan Jose, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock CorporationDien Ban Bac Ward Da Nang, VietnamManufacturer0000api.fda.gov
QUIROPRODUCTOS DE CUAUHTEMOC S. de R.L. de C.V.CUAUHTEMOC, CHIHUAHUA Mexico, MexicoManufacturer0000api.fda.gov
Quiroproductos de Cuauhtemoc S. De R.L. de C.V.Cuauhtemoc Chihuahua, MexicoManufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
SOLVENTUM US LLC (Apodaca)Apodaca Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
Stevimed Medical Joint Stock CompanyCan Giuoc Commune Tay Ninh, VietnamManufacturer0000api.fda.gov
Shanghai Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Solventum US LLCBrookings, SD, United StatesManufacturer0000api.fda.gov
Vien Phat Import Export Service Trading Joint Stock CompanyBen Thanh Ward Ho Chi Minh, VietnamManufacturer0000api.fda.gov
VT Production Medical Materials Production CorporationCan Giuoc Commune Tay Ninh, VietnamManufacturer0000api.fda.gov

Updated May 14, 1985. 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.