Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012552122

FEI Number

3012552122

Entity Name

SHANGHAI MEKON MEDICAL DEVICES CO., LTD.

City/State/Country

shanghai, CN

Establishment Address

526, No. 697-3 Lingshi Road Shanghai China, shanghai 200072, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shanghai Mekon Medical Devices Co., Ltd. (Owner Number: 10059181)

Owner / Operator Contact Address

526, No. 697-3 Lingshi Road Shanghai China, shanghai, CN-SH 200072, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242956

PMA Number

N/A

All Registered Proprietary Names

oral syringe; oral dispensing syringe Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles Manual Vacuum-Assisted Blood Collection System OcuJect Ophthalmic Needle Needle OcuSafe® Ophthalmic Needle; VitreJect® Safety Ophthalmic Needle; SteriCap® Safety Ophthalmic Needle; Blood Collecting Needles VitreJect® Syringes;VitreJect® Ophthalmic Syringes MiniLoad® Syringes sterile insulin syringe for single use with needle(U-100) sterile insulin syringe for single use with needle(U-40) sterile hypodermic needle for single use Sterile hypodermic syringe for single use with/without needle OcuSafe® Needle;VitreJect® Safety Needle;Needle;LDS Needle OcuSafe® Ophthalmic Needle; VitreJect® Ophthalmic Safety Needle; SteriCap® Safety Needle;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2021-05-17
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2019-12-15
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2024-08-01
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-03-23
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2018-12-09
QLY	Ophthalmic Syringe	General Hospital	Class 2	880.5860	2026-03-23
QNQ	Low Dead Space Piston Syringe	General Hospital	Class 2	880.5860	2026-03-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-03-23
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-04-07
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-11-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-11-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2026-03-23
QYM	Ophthalmic Needle	General Hospital	Class 2	880.5570	2026-03-23
QNS	Low Dead Space Needle, Single Lumen, Hypodermic	General Hospital	Class 2	880.5570	2026-03-23

Official Correspondent

Xuanjin Qu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shanghai Mekon Medical Devices 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012552122. Last updated year: 2026. Please use registration number 3012552122 when referencing this establishment in official correspondence.