SUZHOU BORAGE MEDICAL TECHNOLOGY CO.,LTD.

FDA Device Registration & Listing · Suzhou Jiangsu, CN · Registration 3017025817

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
3017025817
FEI Number
3017025817
Entity Name
SUZHOU BORAGE MEDICAL TECHNOLOGY CO.,LTD.
City/State/Country
Suzhou Jiangsu, CN
Establishment Address
No.9 Shiheshan Road, Dongshan Town, Wuzhong District, Suzhou Jiangsu 215107, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Suzhou Borage Medical Technology Co.,Ltd. (Owner Number: 10086449)
Owner / Operator Contact Address
No.9 Shiheshan Road, Dongshan Town, Wuzhong District, Suzhou, CN-JS 215107, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K090819
PMA Number
N/A

All Registered Proprietary Names

Organic Cotton Tampon, Light Regular Super Super plus Unscented Menstrual Tampon(Light, Regular, Super, Super plus) Organic Cotton Cardboard Applicator Tampon, Regular Super

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2024-05-21
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2022-11-10
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2024-09-06

Official Correspondent

Dandan Wang

US Agent Details

Thomas Tang Business: Shenzhen Joyantech Consulting Co., Ltd. Email: usagent@cefda.com Phone: (631) 7511103

Related Public Records

Same Entity

Suzhou Borage 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
K923985 Personal Products Co. UNSCENTED MENSTRUAL TAMPON 1993-02-19
K151170 Tosama, D.O.O. Tosama 100% Organic Cotton Menstrual Tampon 2015-07-02
K930149 Kimberly-Clark Corp. KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+ 1994-03-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017025817. Last updated year: 2026. Please use registration number 3017025817 when referencing this establishment in official correspondence.
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