PIP

Lancing Device with Ejector

Registry build 21.09.26
36manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (11), Zhejiang (9), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMK
Manufacturer City Province Registered as Device types
Acon Biotech (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 29
Hochuen Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 20
Providence Enterprise Limited Shenzhen Guangdong Contract manufacturer 9
Huaian Hening Medical Instruments Co., Ltd. and its Subsidiary Huaian Junran IMP.&EXP. Trading Co., Ltd. Huaian Jiangsu Contract manufacturer 4
Jetcrown Industrial (Dong Guan) Ltd. Guangdong Guangdong Contract manufacturer 3
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Zhejiang Mediunion Healthcare Group Co., Ltd. Ningbo Zhejiang Contract manufacturer 105
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Shandong Zhushi Pharmaceutical Group Co., Ltd. Heze Shandong Contract manufacturer 65
Jiangsu WLD Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 50
Hefei Mlush Sanitary Products Co., Ltd. Hefei Anhui Manufacturer 48

Showing 12 of 36. All 36 manufacturers in China registered for Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Record

Regulatory record for PIP
Listed by Amity Holdings, LLC
FDA product code FMK
Device type Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device class Class 2
Regulation 21 CFR 878.4850
510(k) K230712
Record published 2019-12-30
Record revised 2026-03-12 (version 6)

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
Packaging Corrugate carton of 4, chipboard carton of 100, corrugate carton of 10, chipboard carton of 10, chipboard carton of 30, corrugate carton of 100
Sizes Needle gauge 28 to 33 G; length 1 to 1.8 mm
Distribution end date 2025-12-31

Catalogue Numbers

Catalogue numbers for PIP
Catalogue number Size Status
903 Needle Gauge 28 G In distribution
901 Needle Gauge 30 G In distribution
902 Needle Gauge 30 G In distribution
934 Needle Gauge 33 G Withdrawn
935 Withdrawn
202TK Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 35
Verifine Promisemed Medical Devices Inc. 32
McKesson Mckesson Medical-Surgical Inc. 29
Medline Medline Industries, Inc. 28
SurgiLance Safety Lancet Medipurpose PTE. Ltd. 26
Twist Lancet (32G) Shandong Lianfa Medical Plastic Products Co., Ltd. 25
xinle Hebei Xinle SCI&Tech Co., Ltd. 24
Twist Lancet (31G) Shandong Lianfa Medical Plastic Products Co., Ltd. 24
Twist Lancet (33G) Shandong Lianfa Medical Plastic Products Co., Ltd. 23
Twist Lancet (30G) Shandong Lianfa Medical Plastic Products Co., Ltd. 19
Unistik 3 Owen Mumford Limited 18
Safety Lancet (21GBlade) Shandong Lianfa Medical Plastic Products Co., Ltd. 16

Showing 12 of 345. All products under Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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