Mini Pillow

Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigation during endoscopy helps to maintain a clear visual field…

Registry build 21.09.26

Mini Pillow is a single use, sterile irrigation system that is used during endoscopy and in particular ureterorenoscopy. Irrigation during endoscopy helps to maintain a clear visual field by displacing blood, stone fragments, and cellular debris. Mini Pillow is designed for controlled irrigation through an endoscope or accessory during urological procedures.

6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (4), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FFY
Manufacturer City Province Registered as Device types
Zhejiang Chuangxiang Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Yangzhou Fartley Medical Instrument Technology Co., Ltd. Yangzhou Jiangsu Contract manufacturer 24
Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 17
Smartdata Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 11
Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. Changzhou Jiangsu Manufacturer 14
Changzhou Endoclean Medical Device Co., Ltd. Changzhou Jiangsu Repacker / relabeller 13

Record

Regulatory record for Mini Pillow
Listed by Wismed PL SP Z O O
FDA product code FFY
Device type Adaptor, Bulbs, Miscellaneous, For Endoscope
Device class Class 1
Regulation 21 CFR 876.1500
Premarket notification Exempt
Record published 2025-03-17

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number
Storage Handling environment temperature up to 104 °F; Storage environment temperature up to 104 °F
Packaging Box of 10, box of 60

Catalogue Numbers

Catalogue numbers for Mini Pillow
Catalogue number Size Status
1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Fujifilm Fujifilm Corporation 43
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 7
Cleanascope Cantel Medical (Italy) SRL 6
Cleanascope Advantage Cantel Medical (Italy) SRL 6
mytaMed Mytamed, Inc. 5
Andorate® Air/Water Channel Cleaning Adapter GA Health Company Limited 5
VitreQ Vitreq B.V. 5
SpyGlass Boston Scientific Corporation 4
CAP Chain Olympus Medical Systems Corp. 4
Air/Water Channel Cleaning Adapter GA Health Company Limited 4
Olympus Olympus Winter & IBE Gmbh 4
CeroFrict SML MED-Tech Solutions Limited 4

Showing 12 of 53. All products under Adaptor, Bulbs, Miscellaneous, For Endoscope

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