Uflo

The uFlo device is a single-use disposable accessory to an indwelling urinary catheter intended for administration and withdrawal of physician-specified fluids from the bladder.

Registry build 21.09.26
5manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (3), Shandong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EYI
Manufacturer City Province Registered as Device types
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Hynaut Health Technology Co., Ltd. Qingdao Shandong Contract manufacturer 68
Shanghai NEO-Medical Import & Export Co., Ltd. Shanghai Shanghai Exporter 59
Zhejiang Anji Huabu Industrial Co., Ltd. Huzhou Zhejiang Contract manufacturer 32

Record

Regulatory record for uFlo
Listed by Human Hydrology Devices, Inc., United States
FDA product code EYI
Device type Adaptor, Ureteral Catheter
Device class Class 1
Regulation 21 CFR 876.5130
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2026-07-16

Specifications

Specifications
MRI safety MR Unsafe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case

Catalogue Numbers

Catalogue numbers for uFlo
Catalogue number Size Status
Non-Sterile In distribution
Sterile In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Baxter Baxter Healthcare Corporation 2
Addto Addto, Inc. 1
LSL Healthcare Lsl Industries, Inc. 1
Forté® Y- Adapter Seal Applied Medical Resources Corp. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer