Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016847796

FEI Number

3016847796

Entity Name

NINGBO DAREN MEDICAL TECHNOLOGY CO.,LTD.

City/State/Country

Yuyao Zhejiang, CN

Establishment Address

Macaotou Village, Mazhu Town, Yuyao Zhejiang 315400, CN

Establishment Type(s)

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

Owner / Operator

NINGBO DAREN MEDICAL TECHNOLOGY CO.,LTD. (Owner Number: 10068843)

Owner / Operator Contact Address

Macaotou Village, Mazhu Town, Yuyao, CN-ZJ 315400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bath Chair Vacuum Handrail Rollator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2020-04-10
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2020-04-10
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2020-04-10

Official Correspondent

ZOE CHEN

US Agent Details

Noah Zhang Business: HyperCert Limited Email: noah.zhang@hycerglobal.com Phone: (863) 3233636

Related Public Records

Same Entity

NINGBO DAREN 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016847796. Last updated year: 2026. Please use registration number 3016847796 when referencing this establishment in official correspondence.