Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012461127

FEI Number

3012461127

Entity Name

SHANDONG CAREMED MEDICAL PRODUCTS CO.,LTD.

City/State/Country

Heze Shandong, CN

Establishment Address

YanTai Industrial Park, Ding Tao Country, East of Zhanqian Road, Heze Shandong 274100, CN

Establishment Type(s)

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

Owner / Operator

Shandong Caremed Medical Products Co.,Ltd. (Owner Number: 10050312)

Owner / Operator Contact Address

YanTai Industrial Park, Ding Tao Country, East of Zhanqian Road, Heze, CN-SD 274100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Syringe, piston Needle, hypodermic, single lumen NEEDLE, DENTAL Insulin Syringe, piston Set, administration, intravascular Needle, hypodermic, single lumen Needle, hypodermic, single lumen Syringe, irrigating (dental)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-11-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-05-17
DZM	Needle, Dental	Dental	Class 1	872.4730	2017-06-29
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2017-02-15
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2017-02-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-02-23
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-04-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2016-11-27
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2017-04-06

Official Correspondent

Haibo Li

US Agent Details

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

Related Public Records

Same Entity

Shandong Caremed Medical Products 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
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
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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012461127. Last updated year: 2026. Please use registration number 3012461127 when referencing this establishment in official correspondence.