Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011298700

FEI Number

3011298700

Entity Name

SHANGHAI WARMYOU INDUSTRY CO.,LTD.

City/State/Country

Shanghai, CN

Establishment Address

No. 53 Lane 118 Tangfu Road, Jinhui Town, Fengxian District, Shanghai 201405, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Shanghai Warmyou Industry Co.,Ltd. (Owner Number: 10049656)

Owner / Operator Contact Address

4th Floor ,Tower 18, Zone C,No.1555, West Jinshajiang Road, JIading District, Shanghai, CN-SH 201803, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EyeGiene EyeGiene Insta-Warmth Eye Compression ZEISS Warm Eye Mask

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	2015-07-06

Official Correspondent

Tina Miao

US Agent Details

Jingyi Sun Email: lvpan@warmpad.com Phone: (650) 2241604

Related Public Records

Same Entity

Shanghai Warmyou Industry 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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3017103360	RAIN EYE DROPS LLC	Wilmington, DE, US
3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011298700. Last updated year: 2026. Please use registration number 3011298700 when referencing this establishment in official correspondence.