Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007748805

FEI Number

3007748805

Entity Name

Hangzhou Huanyu Enterprise Co

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

NO.1 DENGCHENG SOUTH ROAD, XINDENG TOWN, FUYANG DISTRICT, Hangzhou Zhejiang 311404, CN

Establishment Type(s)

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

Owner / Operator

HANGZHOU HUANYU ENTERPRISE CO (Owner Number: 10042533)

Owner / Operator Contact Address

NO.1 DENGCHENG SOUTH ROAD, XINDENG TOWN, FUYANG, HANGZHOU, CN-ZJ 311404, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEF	Ring, Teething, Non-Fluid Filled	Dental	Class 1	872.5550	2012-12-06

Official Correspondent

Zoe Zhan

US Agent Details

Andrew Farhat Business: Kids II Email: ProductIntegrity@kidsii.com Phone: (770) 7510442

Related Public Records

Same Entity

HANGZHOU HUANYU ENTERPRISE CO

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

View Entity Profile →

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3010435282	KIDS II FAR EAST LIMITED	Tsim Sha Tsui, Kowloon, Hong Kong, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007748805. Last updated year: 2026. Please use registration number 3007748805 when referencing this establishment in official correspondence.