Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004138517

FEI Number

3004138517

Entity Name

NIPRO (SHANGHAI) CO., LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

2555 BAOAN ROAD, MALU TOWN, JADING DISTRICT, SHANGHAI 201801, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NIPRO CORPORATION (Owner Number: 8030375)

Owner / Operator Contact Address

3-26, Senriokashinmachi, Settsu, JP-27 566-8510, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K052474

PMA Number

N/A

All Registered Proprietary Names

Nipro Hypodermic Needle

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	2005-12-16

Official Correspondent

Nobuhiro Morimoto

US Agent Details

JESSICA OSWALD-MCLEOD Business: NIPRO MEDICAL CORPORATION Email: JessicaO@nipromed.com Phone: (305) 4326699

Related Public Records

Same Entity

NIPRO CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016250252	SHIBUYA CORPORATION	Kanazawa Ishikawa, JP
9610987	NIPRO CORPORATION ODATE FACTORY	ODATE-SHI Akita, JP
3010377171	PT. Nipro Indonesia Jaya	Karawang Jawa Barat, ID
9611446	NIPRO MEDICAL INDUSTRIES LTD.	TATEBAYASHI-SHI Gunma, JP
1056186	NIPRO MEDICAL CORPORATION	Doral, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004138517. Last updated year: 2026. Please use registration number 3004138517 when referencing this establishment in official correspondence.