Curaplex

*Custom* Curaplex Children's Hospital Kit Yellow Pouch

Registry build 21.09.26
93manufacturers in China registered for this device type
5catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (29), Guangdong (28), Jiangsu (17). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BSY
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Amsino Medical (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 22
Primecare Medical (Suzhou) Co., Ltd. Changshu Jiangsu Contract manufacturer 20
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. Shuyang Jiangsu Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Tylenol Medical Instruments Co., Ltd. Zhongshan Guangdong Contract manufacturer 15
Zhejiang Baite Medical Appliances Co., Ltd. Huzhou Zhejiang Contract manufacturer 13
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12
Shenzhen Insighters Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10

Showing 12 of 93. All 93 manufacturers in China registered for Catheters, Suction, Tracheobronchial

Record

Regulatory record for Curaplex
Listed by Bound Tree Medical, LLC, United States
FDA product code BSY
Device type Catheters, Suction, Tracheobronchial
Device class Class 1
Regulation 21 CFR 868.6810
Establishment Manufacturer
Premarket notification Exempt
Record published 2017-09-04
Record revised 2024-03-20 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 10, case of 50
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number Size Status
10369 In distribution
8600-01493 In distribution
8600-01490 In distribution
533-MS-001PMP In distribution
533-MS-002PMP In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ballard™ SunMed Group Holdings, LLC 214
Res-Q-Vac Repro-Med Systems, Inc. 201
DAR Covidien LP 185
Ballard* Closed Suction System for Adults Avanos Medical, Inc. 108
Suction Catheter Well Lead Medical Co., Ltd. 97
Avanos Avanos Medical, Inc. 63
Ballard* Closed Suction System Avanos Medical, Inc. 57
Ballard* Turbo-Cleaning Closed Suction System Avanos Medical, Inc. 57
Medline Medline Industries, Inc. 49
ProCure Twin Med, LLC 47
AirLife™ Airlife, Inc. 44
Closed Suction Catheters Ningbo Xinwell Medical Technology Co., Ltd. 38

Showing 12 of 147. All products under Catheters, Suction, Tracheobronchial

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