Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004416208

FEI Number

3004416208

Entity Name

JUMIN BIO-TECHNOLOGIES, CO., LTD

City/State/Country

Fengxian District Shanghai, CN

Establishment Address

396 Renjie South Road, Fengxian District Shanghai 201400, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jumin Bio-Technologies, Co., Ltd (Owner Number: 9058109)

Owner / Operator Contact Address

396 Renjie South Road, Fengxian District, CN-SH 201400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vanishpoint multiple Vanishpoint Easypoint Vanishpoint VanishPoint syringe VanishPoint Blood Collection Set EasyPoint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-11-13
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2006-08-25
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-11-13
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-04-19
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-11-13
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2007-11-16
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-11-24
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-11-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-11-09

Official Correspondent

SANBA YANG

US Agent Details

Michele Larios Business: Retractable Technologies Inc Email: rtilegal@retractable.com Phone: (972) 2941010

Related Public Records

Same Entity

Jumin Bio-Technologies, Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K092413	Inviro Medical Devices, Inc.	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	2009-09-04
K163162	Jiangxi Hongda Medical Equipment Group , Ltd.	Sterile Hypodermic Safety Syringes for Single Use	2017-03-20
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Similar Registrations

Registration Number	Establishment Name	Location
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3012116434	ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD.	Taihu Anhui, CN
3015528193	Almac Pharma Services (Ireland) Limited	Dundalk Louth, IE
3008719222	ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd	HANGZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004416208. Last updated year: 2026. Please use registration number 3004416208 when referencing this establishment in official correspondence.