Premium Plus

Dental oral evacuators

Registry build 21.09.26
14manufacturers in China registered for this device type
29catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (7), Shanghai (3), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEA
Manufacturer City Province Registered as Device types
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Kindly Enterprise Development Group Co., Ltd. Jiading Shanghai Contract manufacturer 11
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Ningbo Chibanda IMP &EXP Co., Ltd. Ningbo Zhejiang Manufacturer 59
Premium Plus (Dongguan) Limited Dongguan Guangdong Repacker / relabeller 34
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Hangzhou Kangji Medical Instrument Co., Ltd. Hangzhou Zhejiang Contract manufacturer 27
Ningbo Hanyue Medical Technology Co., Ltd. Cixi Zhejiang Contract manufacturer 27
Tonglu Wanhe Medical Instrument Co., Ltd. Hangzhou Zhejiang Manufacturer 24

Showing 12 of 14. All 14 manufacturers in China registered for Cannula, Surgical, General & Plastic Surgery

Record

Regulatory record for Premium Plus
Listed by Premium Plus International Limited, Hong Kong
FDA product code GEA
Device type Cannula, Surgical, General & Plastic Surgery
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2019-12-25

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Label carries lot or batch number
Packaging Case of 4, box of 25, box of 10, case of 100, box of 20
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Premium Plus
Catalogue number Size Per pack Status
335L-ASS 10 In distribution
308-WHITE 100 In distribution
006P-ASS 10 In distribution
335M-ASS 10 In distribution
005M-ASS 10 In distribution
009 25 In distribution
301 100 In distribution
308 100 In distribution
306 In distribution
301-WHITE 100 In distribution
309 100 In distribution
008V 25 In distribution
ST001-LAV 50 In distribution
336P-ASS 10 In distribution
009V 25 In distribution
001-WHITE 100 In distribution
003 100 In distribution
308-ASS 1,000 In distribution
ST001-BLUE 50 In distribution
301-ASS 1,000 In distribution
305 In distribution
001 100 In distribution
205M-ASS 10 In distribution
005L-ASS 10 In distribution
303 100 In distribution
206P-ASS 10 In distribution
001B-ASS 1,000 In distribution
008 25 In distribution
307 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cannula, Surgical, General & Plastic Surgery Black & Black Surgical, Inc. 1,600
Summit Medical Summit Medical LLC 988
Medco Manufacturing Medco Manufacturing LLC 562
Hayden Medical Hayden Medical Inc 457
Cannula, Surgical, General & Plastic Surgery Shippert Medical Technologies Corp. 452
Boss Instruments Boss Instruments, Ltd. 436
Millennium Avalign Technologies, Inc. 281
Black & Black Surgical Black & Black Surgical, Inc. 227
Alira Medical Devices Alira Medical Devices LLC 157
Black & Black Surgical, Inc. Black & Black Surgical, Inc. 154
Aesculap Aesculap AG 134
Euromi Euromi 126

Showing 12 of 608. All products under Cannula, Surgical, General & Plastic Surgery

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