Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011248038

FEI Number

3011248038

Entity Name

Zhejiang Fitmild Biotechnology Co., Ltd.

City/State/Country

Jiaxing Zhejiang, CN

Establishment Address

No. 1166 Zikai West Road, Shimen Town, Tongxiang, Jiaxing Zhejiang 314512, CN

Establishment Type(s)

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

Owner / Operator

Zhejiang Fitmild Biotechnology Co., Ltd. (Owner Number: 10047628)

Owner / Operator Contact Address

No. 1166 Zikai West Road, Shimen Town, Tongxiang, Jiaxing, CN-ZJ 314512, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wound dressings Foam dressings Silicone foam dressings 1. Medical adhesive tapes 2. Transparent dressings 4. Tubing securement device 3. Wound pastes Hydrocolloid dressings Elastic bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2014-10-14
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2014-10-14
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2018-09-19
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2015-07-30

Official Correspondent

Linhe Shen

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (571) 4072862

Related Public Records

Same Entity

Zhejiang Fitmild Biotechnology 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

Similar Registrations

Registration Number	Establishment Name	Location
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3006607005	MOLNLYCKE HEALTH CARE (THAILAND), LTD.	Amphur Muang Chonburi Chon Buri, TH
3015432652	E.L.F. COSMETICS INC	Oakland, CA, US
3043138901	DONGGUAN SAMVO BIOTECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3015215566	THE HAIN CELESTIAL GROUP	Hoboken, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011248038. Last updated year: 2026. Please use registration number 3011248038 when referencing this establishment in official correspondence.