Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008381300

FEI Number

3008381300

Entity Name

WEIHAI HONGYU MEDICAL DEVICES CO., LTD.

City/State/Country

Weihai Shandong, CN

Establishment Address

No. 86 Shenzhen Road, Economy & Technic Development Area, Weihai Shandong 264200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Weihai Hongyu Medical Devices Co., Ltd. (Owner Number: 10032291)

Owner / Operator Contact Address

No. 86 Shenzhen Road, Economy & Technic Development Area, Weihai, CN-SD 264200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

General Gown Disposable Blood Collection Needle Sampling flocked swab Clean-swaps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2010-04-29
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2012-07-23
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-10-29

Official Correspondent

Bin Dong

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Weihai Hongyu Medical Devices 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

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 3008381300. Last updated year: 2026. Please use registration number 3008381300 when referencing this establishment in official correspondence.