Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010375033

FEI Number

3010375033

Entity Name

JIANGSU KERSEN MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Kunshan City Jiangsu, CN

Establishment Address

No 389 Kunjia Rd, Kunshan City Jiangsu 215300, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangsu Kersen Medical Instrument Co., Ltd. (Owner Number: 10087146)

Owner / Operator Contact Address

No 389 Kunjia Rd, Kunshan City, CN-JS 215300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GUIDE WIRE BALL NOSE 100CM, GUIDE WIRE BALL NOSE 80CM EXPEDIUM VERSE SPINE SYSTEM INSERTER/TIGHTENER X25

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-01-17
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2023-01-17

Official Correspondent

Kevin Li

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Jiangsu Kersen Medical Instrument Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010375033. Last updated year: 2026. Please use registration number 3010375033 when referencing this establishment in official correspondence.