Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017079526

FEI Number

3017079526

Entity Name

SHANDONG RUYUE MEDICAL TECHNOLOGY CO.,LTD.

City/State/Country

Binzhou Shandong, CN

Establishment Address

North of xinwuroad, West of gaojiuroad,, High-Tech Industrial Development Zone, Binzhou Shandong 256600, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shandong Ruyue Medical Technology Co.,Ltd. (Owner Number: 10080810)

Owner / Operator Contact Address

North of xinwuroad, West of gaojiuroad,, High-Tech Industrial Development Zone, Binzhou, CN-SD 256600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LIFT, PATIENT, AC-POWERED CRUTCH ADAPTOR, HYGIENE BED, MANUAL BED, AC-POWERED ADJUSTABLE HOSPITAL Patient examination glove SPECTROPHOTOMETRIC, UROPORPHYRIN Walker, mechanical lodine swab APPLICATOR,ABSORBENT TIPPED,NON-STERILE Gauze / sponge,nonresorbable for external use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2024-08-27
IPR	Crutch	Physical Medicine	Class 1	890.3150	2024-08-27
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2024-08-27
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2024-08-27
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-05-17
FMC	Patient Examination Glove	General Hospital	Class 1	880.6250	2021-02-26
JQL	Spectrophotometric, Uroporphyrin	Clinical Chemistry	Class 1	862.1790	2023-05-31
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2024-08-27
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-03-18
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-08-22
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2024-08-22

Official Correspondent

Meizhen Li

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Shandong Ruyue Medical Technology 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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

Similar Registrations

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2428983	GF Health Products, Inc	Atlanta, GA, US
3036834029	SHL HEALTHCARE EAD	Sofia Sofia-Grad, BG
3007031002	KANGHUI MEDICAL TECHNOLOGY (SUZHOU) CO.,LTD	Suzhou Jiangsu, CN
3035641505	BEST HOPEFUL INDUSTRIAL DEVELOPMENT LTD.	HONG KONG, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017079526. Last updated year: 2026. Please use registration number 3017079526 when referencing this establishment in official correspondence.