DeRoyal

Custom Denture and Medicine Cup

Registry build 21.09.26
86manufacturers in China registered for this device type
26catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (22), Guangdong (22), Jiangsu (11). 18 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KYX
Manufacturer City Province Registered as Device types
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Anqing Kangmingna Packaging Co., Ltd. Anqing Anhui Contract manufacturer 39
Shenzhen Senlede Technologies Co., Ltd. Shenzhen Guangdong Contract manufacturer 33
Shanghai Care Us Medical Product Co., Ltd. Shanghai Shanghai Contract manufacturer 30
Hangzhou Primecare Medical Co., Ltd. Hangzhou Zhejiang Contract manufacturer 29
Shun SZE Industrial (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 22
Primecare Medical (Suzhou) Co., Ltd. Changshu Jiangsu Contract manufacturer 20
Sino-Vista Dental Instruments Co., Ltd. Zibo Shandong Contract manufacturer 15
Tung Hing Plastic & Metal(Shenzhen) Co., Ltd. Longgang Dist, Shenzhen Guangdong Contract manufacturer 15
VR Medical Technology Co., Ltd. Kunshan Jiangsu Contract manufacturer 13
BQ Plus Medical Co., Ltd. Songjiang Shanghai Contract manufacturer 13

Showing 12 of 86. All 86 manufacturers in China registered for Dispenser, Liquid Medication

Record

Regulatory record for DeRoyal
Listed by Deroyal Industries, Inc., United States
FDA product code KYX
Device type Dispenser, Liquid Medication
Device class Class 1
Regulation 21 CFR 880.6430
Establishment Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-06-29
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
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 1380, case of 100, case of 50, case of 150, case of 75, case of 25
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for DeRoyal
Catalogue number Size Status
10-3210 In distribution
54-5005 In distribution
HD-395-0060RD In distribution
54-5030 In distribution
HD-395-0060-YL In distribution
54-5003 In distribution
HD-395-0060-GNEU In distribution
31-108 In distribution
HD-395-0060-GN In distribution
54-5060 In distribution
30-173 In distribution
32-1474 In distribution
31-415 In distribution
HD-395-0060-BLEU In distribution
31-169 In distribution
HD-395-0060 In distribution
54-5001 In distribution
HD-395-0060RDEU In distribution
54-5020 In distribution
32-1531 In distribution
54-5010 In distribution
10-3212 In distribution
HD-395-0060-YLEU In distribution
HD-395-0060EU In distribution
32-634 In distribution
HD-395-0060-BL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Doselogix Team Technologies, Inc. 120
PreciseDose Dispenser Medisca Inc. 96
Health Care Logistics, Inc® Health Care Logistics, Inc. 73
MD Ophthalmic Dropper Bottles Medisca Inc. 64
Neomed* Avanos Medical, Inc. 50
Syringe with Tip Cap (For Oral/Topical Use) Medisca Inc. 40
KwikDose Oral Dispenser Medsafety Solutions LLC 30
NeoMed Oral Syringe Neomed Co., Ltd. 28
Enteral Gbuk Group Limited 26
Nutri-LOK Utah Medical Products, Inc. 22
CareTip Gbuk Group Limited 19
Tipguard™ Caps MPS Pharma & Medical, Inc. 18

Showing 12 of 185. All products under Dispenser, Liquid Medication

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