Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008410069

FEI Number

3008410069

Entity Name

Jinhua Ivy Home Textile Co. Limited.

City/State/Country

Jinhua City Zhejiang, CN

Establishment Address

#599 Jiufeng Street, Jinhua City Zhejiang 321000, CN

Establishment Type(s)

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

Owner / Operator

Jinhua Ivy Home Textile Co. Limited. (Owner Number: 10050083)

Owner / Operator Contact Address

#599 Jiufeng Street, Jinhua City, CN-ZJ 321000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Container, Specimen, Non-Sterile pregnency pillow ADAPTOR, HYGIENE Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) disposable face towel Pad, menstrual, reusable Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) BELT, WHEELCHAIR ACCESSORIES, WHEELCHAIR Non-Surgical Gown Orthosis, cervical INSOLES, MEDICAL Thermometer Kit Arm Sling

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2020-12-20
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2026-01-29
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2015-10-12
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-29
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2026-01-29
NUQ	Pad, Menstrual, Reusable	Obstetrics/Gynecology	Class 1	884.5435	2017-02-19
NTX	Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	General Hospital	Class 1	880.5630	2017-02-19
IQB	Belt, Wheelchair	Physical Medicine	Class 1	890.3920	2016-11-24
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2016-11-24
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-29
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2015-10-12
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2016-11-24
PXH	Thermometer Kit	General Hospital	Class 2	880.2910	2020-03-29
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2015-10-12

Official Correspondent

Julie Ni

US Agent Details

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

Related Public Records

Same Entity

Jinhua Ivy Home Textile Co. Limited.

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

Similar Registrations

Registration Number	Establishment Name	Location
3044563538	GAVIN WARD INNOVATIONS LLC	Indianapolis, IN, US
3009474606	AMPAC HOLDINGS, LLC	Cincinnati, OH, US
3043730218	DONGGUAN ZHISHANG SILICONE PRODUCTS CO.,LTD	Dongguan Guangdong, CN
3017771197	ZARAPAK SDN. BHD.	Perak, MY
3016648678	INNOVERO, LLC	Colorado Springs, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008410069. Last updated year: 2026. Please use registration number 3008410069 when referencing this establishment in official correspondence.