Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043648109

FEI Number

3043648109

Entity Name

SUZHOU LETAI MEDICAL TECHNOLOGY CO.,LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.88 Xinyuan Road, Chengxiang Town, Taicang City, Suzhou Jiangsu 215400, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou Letai Medical Technology Co.,Ltd. (Owner Number: 10094973)

Owner / Operator Contact Address

No.88 Xinyuan Road, Chengxiang Town, Taicang City, Suzhou, CN-JS 215400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Seawater Nasal Spray Disposable ECG Electrodes Silicone Scar Gel

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KCO	Nasal Spray, Ent Delivery	Ear, Nose, Throat	Class 1	874.5220	2026-03-12
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2026-01-12
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2026-06-18

Official Correspondent

Xincheng Shi

US Agent Details

Weian Huang Business: JOYSUN USA LLC Email: weian@isosh.com Phone: (949) 4624543

Related Public Records

Same Entity

Suzhou Letai 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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07

Similar Registrations

Registration Number	Establishment Name	Location
3033571062	MERZ PHARMACEUTICALS, LLC	Raleigh, NC, US
1526711	ISOMEDIX OPERATIONS INC	GROVEPORT, OH, US
3010200299	Foundation Consumer Healthcare	Pittsburgh, PA, US
3021011196	E-LINKCARE MEDITECH CO., LTD.	Taizhou Zhejiang, CN
3012896103	SHENZHEN BALINDA TECHNOLOGY CO.,LTD	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043648109. Last updated year: 2026. Please use registration number 3043648109 when referencing this establishment in official correspondence.