Hygitech

Surgical aspiration set compatible with all aspiration systems and composed of: a surgical cannula a filter for collecting bone fragments a 2m PVC tube Supplied with a universal adaptor for…

Registry build 21.09.26

Surgical aspiration set compatible with all aspiration systems and composed of: a surgical cannula a filter for collecting bone fragments a 2m PVC tube Supplied with a universal adaptor for aspiration systems.

23manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (9), Jiangsu (8), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EBR
Manufacturer City Province Registered as Device types
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Shanghai Greeloy Industry Co., Ltd. Shanghai Shanghai Contract manufacturer 9
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Jiangsu Yongfa Medical Equipment Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 33
Shanghai NO. 2 Medical College Duhang Medical Equipment Factory Shanghai Shanghai Contract manufacturer 32
Jiangsu Rooe Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 31

Showing 12 of 23. All 23 manufacturers in China registered for Unit, Suction Operatory

Record

Regulatory record for Hygitech
Listed by Hygitech
FDA product code EBR
Device type Unit, Suction Operatory
Device class Class 1
Regulation 21 CFR 872.6640
Premarket notification Exempt
Record published 2020-11-24
Record revised 2020-12-15 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Box of 20, box of 50, carton of 12, carton of 30, box of 5, carton of 16

Catalogue Numbers

Catalogue numbers for Hygitech
Catalogue number Size Status
HY-12019 In distribution
HY-12031 In distribution
HY-12039 In distribution
HY-12033 In distribution
HY-12014 In distribution
HY-12034 In distribution
HY-12036 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ACE Ace Surgical Supply Co., Inc. 33
Isolite, i3 Zyris, Inc. 24
A-dec A-dec, Inc. 12
Isovac, Connector Zyris, Inc. 9
Aesculap Aesculap AG 8
Isodry Zyris, Inc. 7
Isovac Zyris, Inc. 6
Kohdent Kohler Medizintechnik GmbH 5
Isolite, i2 Zyris, Inc. 3
Maquira Maquira Industria de Produtos Odontologicos S/A 3
Accessories Zyris, Inc. 3
Nordent Manufacturing Inc Nordent Manufacturing Inc 2

Showing 12 of 37. All products under Unit, Suction Operatory

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