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Data / Medical devices / Basin For Endoscope Reprocessing

Basin For Endoscope Reprocessing (PHT): 10 FDA-registered makers in 6 countries

10 establishments in 6 countries are registered with the FDA to make Basin For Endoscope Reprocessing (product code PHT, Class 1, 21 CFR 876.1500). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
PHT
Device class
1
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
Germany4
United States2
Vietnam1
United Kingdom1
Hong Kong1
China1

Makers of Basin For Endoscope Reprocessing

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
CIVCO Medical Instruments Co., Inc.Coralville, IA, United StatesManufacturer0000api.fda.gov
Healthmark Industries Co., Inc.Fraser, MI, United StatesManufacturer, Specification developer0000api.fda.gov
Hoang Nguyen Health Services Equipment Manufacture And Trading Company LimitedLy Thuong Kiet Ward Ninh Binh, VietnamManufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Meditech Endoscopy LtdBasildon Essex, United KingdomManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
SML Med-Tech Solutions LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov

Updated November 2, 2026. 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.