Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009488612

FEI Number

3009488612

Entity Name

JUNTECH (JIAXING) HEALTHCARE MATERIALS CO., LTD.

City/State/Country

Nanhu District, Jiaxing Zhejiang, CN

Establishment Address

No 4 Plant, No 1 build of Northeast of, Yubei St. and Zhengdong Rd, Yuxin Town, Nanhu District, Jiaxing Zhejiang 314009, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Juntech (Jiaxing) Healthcare Materials Co., Ltd. (Owner Number: 10038628)

Owner / Operator Contact Address

No 4 Plant, No 1 build of Northeast of, Yubei St. and Zhengdong Rd, Yuxin Town, Nanhu District, Jiaxing, CN-ZJ 314009, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DETECTORS AND REMOVERS Surgical Respirator SURGICAL APPAREL Mouthpiece Surgical Face Mask MICROSCOPE SLIDE Wound Dressing Tape and bandage MICROSCOPE SLIDE Measuring Tape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJL	Detectors And Removers, Lice, (Including Combs)	General Hospital	Class 1	880.5960	2011-10-28
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-13
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-20
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2021-01-11
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-06-07
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2011-10-28
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-12-03
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2011-11-04
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2011-10-28
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2014-06-19

Official Correspondent

No official correspondent registered.

US Agent Details

Anna Sun Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Juntech (Jiaxing) Healthcare Materials 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06

Similar Registrations

Registration Number	Establishment Name	Location
2248574	AMERICAN COMB CORP.	PATERSON, NJ, US
3021059	TEC LABS	Albany, OR, US
3008809489	ENNOVI MEDICAL	Tamarac, FL, US
3006710549	RFI Hygiene Limited	Shanghai, CN
3011801804	AVEFLOR	Kopidlno Jicin, CZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009488612. Last updated year: 2026. Please use registration number 3009488612 when referencing this establishment in official correspondence.