Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015620563

FEI Number

3015620563

Entity Name

SOL-KL (SHANGHAI) MEDICAL PRODUCTS COMPANY LIMITED

City/State/Country

Shanghai, CN

Establishment Address

Xinpan Road 189, Xinqiao, Songjiang, Shanghai 201612, CN

Establishment Type(s)

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

Owner / Operator

Sol-KL (Shanghai) Medical Products Company Limited (Owner Number: 10061174)

Owner / Operator Contact Address

Xinpan Road 189, Xinqiao, Songjiang, Shanghai, CN-SH 201612, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2019-09-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2020-09-14
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2020-09-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-08-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-04-01
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2020-04-01
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2019-11-27

Official Correspondent

Ivy Chen

US Agent Details

Edward Roles Business: SOL-MILLENNIUM Email: eroles@solm.com Phone: (773) 8376560

Related Public Records

Same Entity

Sol-KL (Shanghai) Medical Products Company Limited

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 3015620563. Last updated year: 2026. Please use registration number 3015620563 when referencing this establishment in official correspondence.