ZENESIS HOLDINGS CO., LIMITED

FDA Device Registration & Listing · Kowloon, HK · Registration 3043012215

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3043012215
FEI Number
3043012215
Entity Name
ZENESIS HOLDINGS CO., LIMITED
City/State/Country
Kowloon, HK
Establishment Address
Unit A7, 12/F, Astoria Building, 34 Ashley Road, Tsim Sha Tsui, Kowloon 999077, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Zenesis Holdings Co., Limited (Owner Number: 10094803)
Owner / Operator Contact Address
Unit A7, 12/F, Astoria Building, 34 Ashley Road, Tsim Sha Tsui, Kowloon, HK-NOTA 999077, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Haelpus Hydrogel wound dressings Haelpus Therapeutic Nursing Pads

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2025-12-24
NTX Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) General Hospital Class 1 880.5630 2025-12-24

Official Correspondent

Ying Qian

US Agent Details

FANFEI LIU Email: U.S.agent@frosatechnology.com Phone: (626) 8261385

Related Public Records

Same Entity

Zenesis Holdings Co., Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043012215. Last updated year: 2026. Please use registration number 3043012215 when referencing this establishment in official correspondence.
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