What is FDA product code FCE?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Gastroenterology & Urology › TherapeuticEnema Kit

Enema Kit

Name: Enema Kit
Brand: Enema Kit

Catalogue number 1.0, listed by Ningbo Albert Novosino Co., Ltd., China, under Enema Kit. 24 manufacturers in China are registered for this product code.

Registry build 21.09.26

24manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (11), Guangdong (5), Zhejiang (4). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FCE
Manufacturer	City	Province	Registered as	Device types
Amsino Medical (Kunshan) Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	53
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Conod Medical Shuyang Co., Ltd.	Shuyang	Jiangsu	Contract manufacturer	22
Shun SZE Industrial (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	22
Primecare Medical (Suzhou) Co., Ltd.	Changshu	Jiangsu	Contract manufacturer	20
Ningbo Albert Novosino Co., Ltd.	Yuyao	Zhejiang	Contract manufacturer	17
Boen Healthcare Co., Ltd.	Suzhou	Jiangsu	Specification developer	263
Jiangsu NEW Pentastar Medical Products Co., Ltd.	Changzhou	Jiangsu	Exporter	146
Huzhou Junda Industry Co., Ltd.	Anji	Zhejiang	Contract manufacturer	129
Sterigenics Shanghai ETO Ltd.	Shanghai	Shanghai	Contract manufacturer	65
Jcmed Tianjin Import AND Export Co., Ltd.	Tianjin	Tianjin	Manufacturer	51
Ningbo Just Soon Industrial Limited	Ningbo	Zhejiang	Repacker / relabeller	36

Showing 12 of 24. All 24 manufacturers in China registered for Enema Kit

Record

Regulatory record for Enema Kit
Listed by	Ningbo Albert Novosino Co., Ltd., China
FDA product code	FCE
Device type	Enema Kit
Device class	Class 1
Regulation	21 CFR 876.5210
Establishment	Contract manufacturer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-11-18

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Enema Kit
Catalogue number	Size	Status
1.0		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Dover	Cardinal Health	10
Cephus Catheter	Sealcath, LLC	5
Dover	Cardinal Health 200, LLC	4
LSL Healthcare	Lsl Industries, Inc.	3
Health Care Logistics, Inc®	Health Care Logistics, Inc.	2
Navina™ Smart System Regular	Wellspect Healthcare	2
Navina™ Classic System Cone Refill	Wellspect Healthcare	2
Premium	Ningbo Albert Novosino Co., Ltd.	2
Navina™Consumable Set Cone	Wellspect Healthcare	2
Navina™ Smart System Small	Wellspect Healthcare	2
Navina™ Classic System Small Refill	Wellspect Healthcare	2
Navina™ Classic System Small	Wellspect Healthcare	1

Showing 12 of 29. All products under Enema Kit

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.