Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010964789

FEI Number

3010964789

Entity Name

ZHEJIANG KELONGWEI MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Shaoxing Zhejiang, CN

Establishment Address

Hangzhou Bay Shangyu Economic and Technological Development Area, Shaoxing Zhejiang 312300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

ZHEJIANG KELONGWEI MEDICAL EQUIPMENT CO., LTD. (Owner Number: 10046911)

Owner / Operator Contact Address

Hangzhou Bay Shangyu Economic and Technological Development Area, Shaoxing, CN-ZJ 312300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pill Cutters/Crushers GRAB BAR Bed Pan Urinal E-Z Bath and shower seat with handle Portable Shower Bench Raised Toilet Seat Uplift Commode Assist Commode Assist Folding Three-in-One Commode DESKTOP PILL ORGANIZER AM/PM WEEKLY PILL BOX Oral Syringe Upeasy Power Seat Uplift Power Seats

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2019-04-04
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2020-04-08
FOB	Bedpan	General Hospital	Class 1	880.6730	2018-11-19
FNP	Urinal	General Hospital	Class 1	880.6730	2018-04-09
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2014-05-29
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2019-09-10
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2020-08-05
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2014-05-29

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

ZHEJIANG KELONGWEI MEDICAL EQUIPMENT 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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10

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3013298431	VEENAK INTERNATIONAL LIMITED	BIRMINGHAM, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010964789. Last updated year: 2026. Please use registration number 3010964789 when referencing this establishment in official correspondence.