Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016766901

FEI Number

3016766901

Entity Name

NINGJIN RUNBODA MEDICAL PROTECTIVE PRODUCTS CO., LTD.

City/State/Country

Xingtai Hebei, CN

Establishment Address

North of Dili Village, Hequ Town, Ningjin County, Xingtai Hebei 055550, CN

Establishment Type(s)

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

Owner / Operator

Ningjin Runboda Medical Protective Products Co., Ltd. (Owner Number: 10089849)

Owner / Operator Contact Address

North of Dili Village, Hequ Town, Ningjin County, Xingtai, CN-HE 055550, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Washing Pad, Fitted Sheet, Bed Sheet, Bed Cover Medical Underpads, Non-woven Bag, Pet Corpse Bag, Body Bag, Washable Incontinence Bed Pad, Reuse-able Bed pad, Shoe Covers, Medical Isolation Shoe Covers, Oversleever Apron Patient Suits, Scrub Suits, Pants Disposable Protective Coveralls, Lab Coat, Isolation Gown, Non-Surgical Gown Adult Diaper, Adult Pull Up Diaper Pants, Incontinence Pad, Napkin Pad Disposable Cap, Medical Cap, Clip Cap, Couffant Cap Face Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-01-14
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2024-01-14
IWO	Apron, Protective	Radiology	Class 1	892.6500	2024-01-14
FME	Gown, Examination	General Hospital	Class 1	880.6265	2024-01-14
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-01-14
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2026-04-12
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2024-01-14
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2024-01-14

Official Correspondent

Yunxiao Wei

US Agent Details

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

Related Public Records

Same Entity

Ningjin Runboda Medical Protective Products Co., Ltd.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016766901. Last updated year: 2026. Please use registration number 3016766901 when referencing this establishment in official correspondence.