Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3031595576

FEI Number

3031595576

Entity Name

SUZHOU SMH CO., LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No. 225 Tuncan East Rd., Tongli Town, Wujiang District, Suzhou Jiangsu 215216, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Suzhou SMH Co., Ltd. (Owner Number: 10091027)

Owner / Operator Contact Address

No. 225 Tuncan East Rd., Tongli Town, Wujiang District, Suzhou, CN-JS 215216, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WarmClear LumClear SPD LC4-SPD5 LumClear SPD LC9-SPD10 TroClear SPD ScopesClear TroClear OR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2026-03-22
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2026-03-22
FXQ	Lens, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2026-03-22
NWV	Laparoscopic Accessories, Gynecologic	Obstetrics/Gynecology	Class 1	884.1720	2024-06-18

Official Correspondent

Bai Jingtao

US Agent Details

Robert Bromley Email: rbromley@mednium.com Phone: (303) 3785463

Related Public Records

Same Entity

Suzhou SMH 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

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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3010039589	RAPID AID CORP.	Wilmington, DE, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031595576. Last updated year: 2026. Please use registration number 3031595576 when referencing this establishment in official correspondence.