Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004099493

FEI Number

3004099493

Entity Name

CHENGDU XINJIN SHIFENG MEDICAL APPARATUS & INSTRUMENT CO., LTD.

City/State/Country

Chengdu Sichuan, CN

Establishment Address

NO. 51, 4th Group Wanjie Village, Baodun Town, 611438 Xinjin District, NO. 3561, Xixin Avenue, Puxing Street, 611435 Xinjin District, Chengdu Sichuan 611438, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., L (Owner Number: 10056352)

Owner / Operator Contact Address

NO. 51, 4th Group Wanjie Village, Baodun Town, 611438 Xinjin District, NO. 3561, Xixin Avenue, Puxing Street, 611435 Xinjin District, Chengdu, CN-SC 611438, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ENTERAL SYRINGE PC SYRINGE Plastcare USA ORAL DISPENSER STERILE NEEDLE safety needle shifeng suction tubing SUCTION TUBING Dental Neelde SAFETY NEEDLE BLUNT NEEDLE BLUNT FILTER NEEDLE Irrigating syringe IV SETS Y-CONNECTOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PNR	Enteral Syringes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2018-06-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2021-02-01
EIB	Syringe, Irrigating (Dental)	Dental	Class 1	872.4565	2019-05-19
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2020-01-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-06-14
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2018-07-22
DZM	Needle, Dental	Dental	Class 1	872.4730	2022-04-16
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-06-14
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2018-06-14
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2021-11-29
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2017-11-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2018-06-14
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2021-08-16

Official Correspondent

NICK WANG

US Agent Details

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

Related Public Records

Same Entity

Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., L

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
K203410	Shantou Wealy Medical Instrument Co.,Ltd	ENFit Disposable Enteral Syringe	2021-06-28
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
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

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 3004099493. Last updated year: 2026. Please use registration number 3004099493 when referencing this establishment in official correspondence.