Breathe Comfort

Breathe Comfort Nasal Irrigator

Registry build 21.09.26
63manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (37), Zhejiang (10), Jiangsu (5). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KMA
Manufacturer City Province Registered as Device types
Shenzhen Xiazhifeng Electronic Co., Ltd. Shenzhen Guangdong Contract manufacturer 25
Andon Health Co., Ltd. Tianjin Tianjin Contract manufacturer 22
Ningbo Albert Novosino Co., Ltd. Yuyao Zhejiang Contract manufacturer 17
Chongqing Sonmol Technology Co., Ltd. Chongqing Chongqing Contract manufacturer 9
Yuyao Guangjing Medical Instrument Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Cotronic Technology Limited Shenzhen, Guang Dong Guangdong Contract manufacturer 5
Shantou City KIN Seng Plastic Co., Ltd. Guangdong Guangdong Contract manufacturer 3
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Jcmed Tianjin Import AND Export Co., Ltd. Tianjin Tianjin Manufacturer 51
Hangzhou Weize IMP & EXP Co., Ltd. Hangzhou Zhejiang Manufacturer 34
Shenzhen Balinda Technology Co., Ltd. Shenzhen Guangdong Manufacturer 23
Aimi Health Technology (Guangdong) Co., Ltd. Dongguan Guangdong Manufacturer 21

Showing 12 of 63. All 63 manufacturers in China registered for Irrigator, Powered Nasal

Record

Regulatory record for Breathe Comfort
Listed by Slv Pharmaceuticals LLC
FDA product code KMA
Device type Irrigator, Powered Nasal
Device class Class 1
Regulation 21 CFR 874.5550
Premarket notification Exempt
Record published 2020-11-18

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, serial number

Catalogue Numbers

Catalogue numbers for Breathe Comfort
Catalogue number Size Status
NASAL IRRIGATOR In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hydrodebrider® Medtronic Xomed, Inc. 9
SinuPulse Health Solutions Medical Products, Corp. 4
iHealth iHealth Labs, Inc. 3
Naväge Rhinosystems, Inc. 3
Berrcom Guangzhou Berrcom Medical Device Co., Ltd. 3
InhwRior Shenzhen Yuechuan Trade Co., Ltd. 2
Braun KAZ USA, Inc. 2
HealthSmart D-M-S Holdings, Inc. 2
Bios Diagnostics Thermor Ltd. 2
Cleaning sheath for Ø3.1mm X 170mm 45° R Henke-Sass Wolf, Gmbh. 1
Cleaning sheath for Ø3.1mm X 170mm 0° Henke-Sass Wolf, Gmbh. 1
Cleaning sheath for Ø4mm X 155mm 45° Henke-Sass Wolf, Gmbh. 1

Showing 12 of 36. All products under Irrigator, Powered Nasal

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