Bonopty Penetration Set

Manually operated, sterile, single use coaxial bone biopsy system.

Registry build 21.09.26
37manufacturers in China registered for this device type
8catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (9), Jiangsu (7), Shanghai (6). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAA
Manufacturer City Province Registered as Device types
Hynaut Health Technology Co., Ltd. Qingdao Shandong Contract manufacturer 68
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
Hantech Medical Device Co., Ltd. Cixi Zhejiang Contract manufacturer 18
Shanghai Kindly Enterprise Development Group Co., Ltd. Jiading Shanghai Contract manufacturer 11
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Taihu Anhui Contract manufacturer 8
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Ningbo Tianbo First AID Product Co., Ltd. Ningbo Zhejiang Repacker / relabeller 66
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Dongguan City Ruimi Gift Products Co Ltd Dongguan Guangdong Repacker / relabeller 62
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Joykey Industrial (Pinghu) Limited Pinghu Zhejiang Contract manufacturer 43

Showing 12 of 37. All 37 manufacturers in China registered for Needle, Aspiration And Injection, Disposable

Record

Regulatory record for Bonopty Penetration Set
Listed by AprioMed AB, Sweden
FDA product code GAA
Device type Needle, Aspiration And Injection, Disposable
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-04-24
Record revised 2026-02-26 (version 3)

Specifications

Specifications
MRI safety MR Unsafe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Packaging Shelf box of 5, transportation box of 12, transportation bix of 12
Sizes Needle gauge 12 to 14 G; length 6.5 to 13 cm
Distribution end date 2026-02-26

Catalogue Numbers

Catalogue numbers for Bonopty Penetration Set
Catalogue number Size Status
G025 Needle Gauge 14 G In distribution
G023 Needle Gauge 14 G In distribution
G030 Needle Gauge 12 G In distribution
G028 Needle Gauge 14 G In distribution
10-1072 Needle Gauge 14 G Withdrawn
12-1272 Needle Gauge 12 G Withdrawn
10-1062 Needle Gauge 14 G Withdrawn
10-1082 Needle Gauge 14 G Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 298
Anodyne Surgical Psi/Eye-Ko, Inc. 148
Zavation Zavation 121
Whiterose Micro Cannula UC Medical 38
Monoject Cardinal Health 33
MagniCore Cook Incorporated 29
Breast localisation needle Möller Medical GmbH 29
CytoCut M.D.L. S.R.L. 28
Chiba Needle Marked Remington Medical, Inc. 26
Walcott Rx Products Psi/Eye-Ko, Inc. 24
Breast Localization Needles Argon Medical Devices, Inc. 23
Fine Needle Aspiration Mermaid Medical A/S 22

Showing 12 of 183. All products under Needle, Aspiration And Injection, Disposable

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