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Data / Medical devices / Bath, Flotation, Tissue

Bath, Flotation, Tissue (IDY): 19 FDA-registered makers in 5 countries

19 establishments in 5 countries are registered with the FDA to make Bath, Flotation, Tissue (product code IDY, Class 1, 21 CFR 864.3010). 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 1 recall event (0 Class I). FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Product code
IDY
Device class
1
Regulation
864.3010
Medical specialty
Pathology

Makers by country

CountryMakers
China6
United States4
India4
Germany3
United Kingdom2

Makers of Bath, Flotation, Tissue

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
Boekel ScientificFeasterville, PA, United StatesManufacturer0000api.fda.gov
Cellpath LtdNEWTOWN Powys, United KingdomSpecification developer0000api.fda.gov
General Data HealthcareCincinnati, OH, United StatesManufacturer0000api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.GUANGZHOU Guangdong, ChinaManufacturer0000api.fda.gov
Jinhua Craftek Instrument Co., LtdJinhua Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Leica Biosystems Nussloch GMBHNUSSLOCH Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
LW Scientific, Inc.Lawrenceville, GA, United StatesManufacturer0000api.fda.gov
Leica Instruments (Shanghai) Co., Ltd.Shanghai, ChinaContract manufacturer, Specification developer0000api.fda.gov
Medimeas InstrumentsAmbala Cantt Haryana, IndiaManufacturer0000api.fda.gov
Medite Medical GMBHBurgdorf Lower Saxony, GermanyManufacturer0000api.fda.gov
Pathnsitu Biotechnologies Pvt LtdHYDERABAD Telangana, IndiaManufacturer0000api.fda.gov
Quanzhou V-Care Sanitary Products Co.,ltdQuanzhou Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Rushabh Instruments, LLCIvyland, PA, United StatesManufacturer0000api.fda.gov
Shandon Diagnostics LimitedRUNCORN Cheshire East, United KingdomManufacturer0000api.fda.gov
Shanghai Youding International Trade Co., Ltd.Shanghai, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Sipcon Technologies Private LimitedAmbala Haryana, IndiaManufacturer0000api.fda.gov
Slee Medical GMBHNieder-Olm Rhineland-Palatinate, GermanyContract manufacturer, Foreign private label distributor, Manufacturer0000api.fda.gov
Uni Meditrek Private LimitedGhaziabad Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Zhejiang Gene Science Co., Ltdshaoxing Zhejiang, ChinaManufacturer0000api.fda.gov

Updated November 3, 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.