Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004143450

FEI Number

3004143450

Entity Name

SHANGHAI CARELIFE INTERNATIONAL TRADING CO. LTD

City/State/Country

Jinqiao Pudong Shanghai, CN

Establishment Address

room 1707 Yinqiao Building, No 58, Jinxin Road, Jinqiao Pudong Shanghai 201206, CN

Establishment Type(s)

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

Owner / Operator

Shanghai Carelife International Trading Co. LTD (Owner Number: 10035047)

Owner / Operator Contact Address

room 1707 Yinqiao Building, No 58, Jinxin Road, Jinqiao Pudong, CN-SH 201206, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CARETOUCH JJ CARE MedtPoint JJ Care Insulin Syringe for Pets JJ Care Insulin Syringe PLASDENT Dynarex Safety Lancets Global Lancets MEDICORE Lancets CARETOUCH Medt ULTILET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-06-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-01-26
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2014-07-29
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2016-12-30
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2016-12-21
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2023-05-22
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2023-05-22
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2017-08-01
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-08-01
DZM	Needle, Dental	Dental	Class 1	872.4730	2013-03-03
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-01-27
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2011-01-28

Official Correspondent

Li Qian

US Agent Details

LI QIAN Business: Carelife USA Inc. Email: li@carelifeusa.com Phone: (770) 9356499

Related Public Records

Same Entity

Shanghai Carelife International Trading 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
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
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

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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004143450. Last updated year: 2026. Please use registration number 3004143450 when referencing this establishment in official correspondence.