The Insides Neo

The Insides Neo x1 Pouch

Registry build 21.09.26
18manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Zhejiang (4), Shanghai (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EXB
Manufacturer City Province Registered as Device types
Nanjing Anjian Medical Device Co., Ltd. Nanjing Jiangsu Contract manufacturer 22
Shaoxing Haoshide Medical Products Co., Ltd. Shaoxing Zhejiang Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Jiangsu WLD Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 50
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Rozer Sterilization Technology Shuyang Company Limited Shuyang Jiangsu Contract manufacturer 33
Dongguan Hong De Medical Plastic Products Co., Ltd. Dongguan Guangdong Contract manufacturer 32
Aimi Health Technology (Guangdong) Co., Ltd. Dongguan Guangdong Manufacturer 21
Wenzhou Zuoyou Medical Technoloyg Co., Ltd. Wenzhou Zhejiang Contract manufacturer 21

Showing 12 of 18. All 18 manufacturers in China registered for Collector, Ostomy

Record

Regulatory record for The Insides Neo
Listed by THE Insides Company Limited, New Zealand
FDA product code EXB
Device type Collector, Ostomy
Device class Class 1
Regulation 21 CFR 876.5900
Establishment Manufacturer
Premarket notification Exempt
Record published 2025-10-16
Record revised 2025-10-16 (version 2)

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date, serial number
Packaging Carton of 10, pouch – sample of 3
Distribution end date 2025-10-16

Catalogue Numbers

Catalogue numbers for The Insides Neo
Catalogue number Size Status
PS031 In distribution
PS028 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Assura Coloplast A/S 252
New Image Hollister Incorporated 236
SenSura Mio Coloplast A/S 200
Premier Hollister Incorporated 182
SenSura Mio Convex Coloplast A/S 162
SenSura Mio Convex brand logo Coloplast A/S 82
SenSura Click Coloplast A/S 69
Securi-T Hollister Incorporated 59
SenSura Mio Convex Flip Coloplast A/S 58
SenSura Coloplast A/S 53
Karaya 5 Hollister Incorporated 38
Sensura Flex Coloplast A/S 37

Showing 12 of 31. All products under Collector, Ostomy

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