Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016733390

FEI Number

3016733390

Entity Name

SUNKISS HEALTHCARE(ZHEJIANG) CO., LTD

City/State/Country

HANGZHOU Zhejiang, CN

Establishment Address

NO.6 PANLONGSHAN ROAD, CHANGKOU NEW ZONE, FUYANG, HANGZHOU Zhejiang 311400, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Sunkiss Healthcare(Zhejiang) Co., Ltd (Owner Number: 10063745)

Owner / Operator Contact Address

NO.6 PANLONGSHAN ROAD, CHANGKOU NEW ZONE, FUYANG, HANGZHOU, CN-ZJ 311400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pad, Menstrual, Unscented, Period Underwear, Period Pad Masks Masks

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	Class 1	884.5435	2020-03-21
FXO	Suit, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-21
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-05-08

Official Correspondent

Dejuan Hu

US Agent Details

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

Related Public Records

Same Entity

Sunkiss Healthcare(Zhejiang) 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
K823241	Kimberly-Clark Corp.	NEW FREEDOM THIN UNSCENTED MAXI PADS	1982-12-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016733390. Last updated year: 2026. Please use registration number 3016733390 when referencing this establishment in official correspondence.