Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036893546

FEI Number

3036893546

Entity Name

JIANGSU SENWO MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Nantong Jiangsu, CN

Establishment Address

No.6, Huanghai Road, Hi-Tech Industrial Development Zone, Qidong, Nantong Jiangsu 226200, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangsu Senwo Medical Technology Co., LTD. (Owner Number: 10092723)

Owner / Operator Contact Address

No.6, Huanghai Road, Hi-Tech Industrial Development Zone, Qidong, Nantong, CN-JS 226200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Wet Wipes, Alcohol Wet Wipes, Cotton Wet Wipes, Toilet Wet Wipes, Snot Wipes Baby Wipes, Hand Wipes, Tableware Wipes, Disinfectant Wet Wipes, Feminine Wet Wipes; Breast Pump Wipes, BD03; Wet Wipes, Nipple Protective Cups Maternity support belt PORTABLE BIDET, POSTPARTUM CARE, PERSONAL HYGIENE CARE, Vaginal Douche Saline Spray, Cracked Nipple Saline Spray, NURSING PAD Elastomer Silicone, For Scar Management Pack, Hot or Cold, Reusable PACK, HOT OR COLD, DISPOSABLE Mom Pain + Strain Relief Tape, TAPE AND BANDAGE, ADHESIVE, Cooling Bandage Splint Intranasal Septal, CBER Led, INSULIN VIAL PROTECTOR/HOLDER ACCESSORY, SURGICAL APPAREL Disposable Underwear Stocking, Medical Support (For General Medical Purposes)- Compression Socks Breathe Patch NURSING PAD, HYDROGEL BOTTLE, HOT/COLD WATER Non-surgical Gown ADAPTOR, HYGIENE Motion Recovery Tape

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-02-11
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2025-02-11
ISR	Band Or Belt, Pelvic Support	Physical Medicine	Class 1	890.3025	2026-03-04
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-02-11
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2025-02-11
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2025-02-11
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-02-11
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2025-02-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-02-11
QJL	Splint, Intranasal Septal, Cber Led	Ear, Nose, Throat	Class 1	874.4780	2025-02-11
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2025-02-11
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2025-02-11
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2025-02-11
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2025-12-10
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2025-02-11
FPF	Bottle, Hot/Cold Water	General Hospital	Class 1	880.6085	2025-02-11
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2025-02-11
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2025-02-11
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2025-02-11

Official Correspondent

Xianfu Ma

US Agent Details

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

Related Public Records

Same Entity

Jiangsu Senwo 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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3007031049	MINIPAC PRODUCTS LTD	Kadima-Zoran Central, IL
3008697511	Geann Industrial Co Ltd	Lukang Town Changhua, TW
1526481	KLEEN TEST PRODUCTS CORPORATION	Strasburg, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036893546. Last updated year: 2026. Please use registration number 3036893546 when referencing this establishment in official correspondence.