Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007766648

FEI Number

3007766648

Entity Name

Zhejiang OneHealth Medical Technology Co., Ltd

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No. 108, Kenhui 2nd Road, National Economic Development Zone, Xiaoshan District, Hangzhou Zhejiang 311231, CN

Establishment Type(s)

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

Owner / Operator

Zhejiang OneHealth Medical Technology Co., Ltd (Owner Number: 10029194)

Owner / Operator Contact Address

No. 108, Kenhui 2nd Road, National Economic Development Zone, Xiaoshan District, Hangzhou, CN-ZJ 311231, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hydrogel Wound Dressing Tape and bandage, adhesive Dressing, wound, hydrophilic

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	2026-01-15
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2009-04-16
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2009-04-16

Official Correspondent

Fanqiang Zhao

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

Zhejiang OneHealth Medical Technology 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007766648. Last updated year: 2026. Please use registration number 3007766648 when referencing this establishment in official correspondence.