SunMed

Bougie-TO-GO- Adult (E/T Introducer W/ Coude TIP)

Registry build 21.09.26
34manufacturers in China registered for this device type
22catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (10), Jiangsu (9), Guangdong (8). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BSR
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Modern Medical Equipment Manufacturing Ltd. Heng Li, Dongguan Guangdong Contract manufacturer 26
Modern Medical Equipment Manufacturing (Qing Yuan) Ltd Qing Yuan Guangdong Contract manufacturer 26
Hitec Medical Co., Ltd. Shanghai Shanghai Contract manufacturer 17
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou Zhejiang Contract manufacturer 11
Shenzhen Insighters Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Hangzhou Formed Medical Devices Co., Ltd. Hangzhou Zhejiang Contract manufacturer 9
Tianjin Medis Medical Device Co., Ltd. Tianjin Tianjin Contract manufacturer 5
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263

Showing 12 of 34. All 34 manufacturers in China registered for Stylet, Tracheal Tube

Record

Regulatory record for SunMed
Listed by SunMed Group Holdings, LLC, United States
FDA product code BSR
Device type Stylet, Tracheal Tube
Device class Class 1
Regulation 21 CFR 868.5790
Establishment Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2026-02-18
Record revised 2026-05-01 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 20
Sizes Length 10 to 12.5 in
Distribution end date 2026-06-15
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for SunMed
Catalogue number Size Status
09-0203-14 Length 12.5 in In distribution
9-0210-01 In distribution
9-0213-92 In distribution
9-0212-72 In distribution
9-0213-82 In distribution
9-0212-82 In distribution
9-0204-22 In distribution
9-0212-70 In distribution
9-0212-80 In distribution
9-0204-25 In distribution
9-0209-72 In distribution
9-0204-11 In distribution
9-0211-70 In distribution
9-0209-71 In distribution
9-0204-12 In distribution
09-0203-06 Length 10 in In distribution
09-0203-10 Length 11.5 in In distribution
9-0209-73 In distribution
9-0204-10 In distribution
9-0204-00 In distribution
9-0207-03 Withdrawn
9-0207-01 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Stylet, Tracheal Tube VBM Medizintechnik Gmbh 17
Hudson RCI Teleflex Medical LLC 16
SourceMark Sourcemark, LLC. 13
Intubating Stylet Well Lead Medical Co., Ltd. 11
AincA® Anesthesia Associates, Inc. 8
Medline Medline Industries, Inc. 8
Sheridan Teleflex Medical LLC 7
Rusch Teleflex Medical LLC 6
Cardinal Health Cardinal Health 200, LLC 4
Anesthesia Sunset Healthcare Solutions, Inc. 4
Vital Signs™ Airlife, Inc. 4
Portex ICU Medical, Inc 4

Showing 12 of 86. All products under Stylet, Tracheal Tube

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