NeoSeal®

The NeoSeal is intended to create a seal around the nares and protect the skin of the septum and nares. It is intended for use on pediatric (neonates, infants and children) patients.

Registry build 21.09.26
17manufacturers in China registered for this device type
3catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code BXJ
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 12
Flying Tooling Engineering Limited Dongguan Guangdong Contract manufacturer 9
Ningbo Boya Medical Equipment Co., Ltd. Yuyao Zhejiang Contract manufacturer 8
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
Shenzhen Xiazhifeng Electronic Co., Ltd. Shenzhen Guangdong Contract manufacturer 25
Suzhou Shangchuang Technology Service Co., Ltd. Suzhou Jiangsu Manufacturer 23
Dongguan Yipincheng Technology Co., Ltd. Dongguan Guangdong Manufacturer 17
Shaoxing Undis Medical Technology Company Limited Shaoxing Zhejiang Manufacturer 17

Showing 12 of 17. All 17 manufacturers in China registered for Clip, Nose

Record

Regulatory record for NeoSeal®
Listed by Neotech Products, LLC, United States
FDA product code BXJ
Device type Clip, Nose
Device class Class 1
Regulation 21 CFR 868.6225
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-05-19
Record revised 2023-09-25 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for NeoSeal®
Catalogue number Size Per pack Status
Small 150 In distribution
Large 150 In distribution
Micro 150 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Curaplex Bound Tree Medical, LLC 6
Noseclip Vitalograph Ireland Ltd. 6
Jaeger Jaeger Medical GmbH 6
Vyaire Jaeger Medical GmbH 4
nSpire Health Nspire Health, Inc. 4
Disposable Blue PFT Nose Clip with Rubber Pads A-M Systems 2
Disposable PFT Nose Clip with Rubber Pads A-M Systems 2
Noseclip, Disposable, White, Foam Pad A-M Systems 2
Disposable Blue PFT Nose Clip with Foam Pads A-M Systems 2
Nose Clip Intersurgical Ltd. 2
Disposable PFT Nose Clip with Foam Pads A-M Systems 2
Nose Clips VectraCor, Inc. 2

Showing 12 of 39. All products under Clip, Nose

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