CeroFrict

Disposable Endoscope Tip Protector

Registry build 21.09.26
6manufacturers in China registered for this device type
4catalogue numbers in this listing

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 CeroFrict
Listed by SML MED-Tech Solutions Limited, Hong Kong
FDA product code FFY
Device type Adaptor, Bulbs, Miscellaneous, For Endoscope
Device class Class 1
Regulation 21 CFR 876.1500
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-05-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 75, pack of 4

Catalogue Numbers

Catalogue numbers for CeroFrict
Catalogue number Size Status
SML007-TP01 In distribution
SML007-TP03 In distribution
SML007-TP04 In distribution
SML007-TP02 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
NON-Sterile Biopsy Valve Covers Batrik Medical Manufacturing Inc. 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