Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014315664

FEI Number

3014315664

Entity Name

Duopross Meditech (Kunshan) Co., Ltd.

City/State/Country

Kunshan Jiangsu, CN

Establishment Address

Taihong Road Yushan Town Wusong Jiang, Kunshan Jiangsu 215300, CN

Establishment Type(s)

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

Owner / Operator

Duopross Meditech (Kunshan) Co., Ltd. (Owner Number: 10056862)

Owner / Operator Contact Address

Taihong Road Yushan Town Wusong Jiang, Kunshan, CN-JS 215300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

insosafe safetytray bak'snap DPS dps bak'snap insosafe safetytray bak'snap insosafe safetytray safetytray bak'snap insosafe safetytray bak'snap insosafe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2018-01-23
IWR	Holder, Syringe, Lead	Radiology	Class 1	892.6500	2026-06-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2018-01-23
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2018-01-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-12-19
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2018-01-23
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2018-01-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-01-23
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2018-01-23

Official Correspondent

Edward Chiu

US Agent Details

Vincent Fu Fu Business: Duopross Meditech Corp Email: vincent.fu@baksnap.com Phone: (631) 2490100

Related Public Records

Same Entity

Duopross Meditech (Kunshan) 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
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Similar Registrations

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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 3014315664. Last updated year: 2026. Please use registration number 3014315664 when referencing this establishment in official correspondence.