DeRoyal

Jackson Memorial Guidewire Bowl 25C

Registry build 21.09.26
115manufacturers in China registered for this device type
22catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (33), Zhejiang (32), Guangdong (13). 24 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NNI
Manufacturer City Province Registered as Device types
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Suzhou Texnet Suzhou Jiangsu Contract manufacturer 47
Hubei V-Medical Products Co., Ltd. Xiantao Hubei Contract manufacturer 46
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. Jingmen Hubei Contract manufacturer 23
Primecare Medical (Suzhou) Co., Ltd. Changshu Jiangsu Contract manufacturer 20
Henso Medical (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 19
Jiangsu Kangjian Medical Apparatus Co., Ltd. Jiangyan Jiangsu Contract manufacturer 19
Hangzhou Stellarmed Medical Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 15

Showing 12 of 115. All 115 manufacturers in China registered for Container, Specimen, Non-Sterile

Record

Regulatory record for DeRoyal
Listed by Deroyal Industries, Inc., United States
FDA product code NNI
Device type Container, Specimen, Non-Sterile
Device class Class 1
Regulation 21 CFR 864.3250
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-08-23
Record revised 2021-10-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 25, case of 20, case of 100, case of 50, case of 150, case of 15
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number Size Status
CAR.BOWL.BL.NS In distribution
CAR.BOWL.BL In distribution
32-881 In distribution
HD-395-3000PINK In distribution
HD-396-0911EU In distribution
HD-396-0911 In distribution
71-1127 In distribution
HD-395-2000CTEU In distribution
HD-395-3000EU In distribution
71-1122 In distribution
32-1345 In distribution
32-1029 In distribution
HD-395-GW2000EU In distribution
71-2066 In distribution
HD-395-GW2000CTEU In distribution
77-400721 In distribution
HD-395-3000 In distribution
HD-395-3000-T In distribution
HD-395-2000CT In distribution
31-111 In distribution
31-669 In distribution
71-1123 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medegen Medical Products, LLC Medegen Medical Products 759
Minigrip Commercial Minigrip Commercial LLC 286
Caplugs/Evergreen Caplugs, Inc. 154
Minigrip Commercial LLC Minigrip Commercial LLC 62
Fisherbrand Fisher Scientific Company L.L.C. 40
Premium Plus Premium Plus International Limited 36
Globe Scientific Globe Scientific, LLC 27
Epredia Richard-Allan Scientific LLC 22
Avaline Medical NJ LLC Avaline Medical NJ Limited Liability Company 16
ASP Medical ASP Global, LLC 15
Leakbuster Starplex Scientific Corp. 14
Cardinal Health Cardinal Health 200, LLC 13

Showing 12 of 124. All products under Container, Specimen, Non-Sterile

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