Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612390

FEI Number

3003255801

Entity Name

Wujiang City Shen Ling Medical Device Co.,Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

East of Building FS-02, No. 807 West Ganquan Road, Jiangling Street, Wujiang District, Suzhou Jiangsu 215200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wujiang City Shen Ling Medical Device Co., Ltd. (Owner Number: 9042446)

Owner / Operator Contact Address

Building 18, No. 148 Yucai Road,, Beishe, Wujiang, CN-JS 215214, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K002411

PMA Number

N/A

All Registered Proprietary Names

Hydra Needle 540 Derma Roller Meso Micro Roller Micro Needle Roller Mesogun Needles Hydra Roller Meso Micro Needles Beard Roller Derma Roller Skin Roller Derma Stamp Mesotherapy Needles Morlake 192 Real Needles Derma Roller Derma Pen Press Tack Needle, Ear needle, Seven Star needle, 3-Edged needle, AcuZone Acupuncture needles, E&Z CARBO, Energy Flo, Peace, Acubest, New Meridian, AA, TAIYI TCM, KSC DB Plus Acupuncture needles, Intradermal needle,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GED	Brush, Dermabrasion, Manual	General, Plastic Surgery	Class 1	878.4800	2021-09-23
KNM	Device, Pressure Applying	Physical Medicine	Class 1	890.5765	2017-09-25
MQX	Needle, Acupuncture, Single Use	General Hospital	Class 2	880.5580	2008-04-22

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

Wujiang City Shen Ling Medical Device 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 9612390. Last updated year: 2026. Please use registration number 9612390 when referencing this establishment in official correspondence.