Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005023997

FEI Number

3005023997

Entity Name

Shanghai Chuangshi Medical Technology (Group) Co., Ltd.

City/State/Country

SHANGHAI, CN

Establishment Address

No.388, Zhangliantang Road, Qingpu, SHANGHAI 201716, 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

Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (Owner Number: 9070346)

Owner / Operator Contact Address

No.388, Zhangliantang Road, Qingpu, Shanghai, CN-SH 201716, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IV Sleeve Pediatric Sleeve PICC Sleeve Cold and hot pack clay based hot &cold wrap Clay Pack Moist heat pad ICE GEL PACK Medical Patch Cool Gel Mat(Pad) Heated Seat Warmer moist heat back wrap moist heat neck wrap HOT AND COLD PACK Forever Cool Small Mat HC1475 MIND & BODY CARE BY SOFTHEAT BODY CARE WRAP, THERAPEUTIC MICROBEADS HC1450 MIND & BODY CARE BY SOFTHEAT, BODY CARE WRAP, THERAPEUTIC MICROBEADS HC1302-B SMARTTEMP REUSABLE LARGE HOT/COLD THERAPY PAD Reusable Cold Wrap With Adjustable Straps HC1201-B SMARTTEMP REUSABLE SMALL HOT/COLD THERAPY PAD JUNIOR EYE PACK Reusable Hot/Cold Eye Compress EYES PACK Reusable Bilateral Hot/Cold Eye Compress(GREEN) EYES PACK Reusable UNILATERAL Hot/Cold Eye Compress(AQUA) Norco Heavy Duty Cold Pack Ice gel box Cool gel mat/pack Cool gel pad Ice gel mat/pad Hot pack Hot mat/pad SPARTHOS Hot cold pack cool&hot therapy mat/pad/pack Cold and hot therapy mat/pad/pack Cold pack, hot/cold pack Ankle Ice pack Silicone Scar Gel intelligent anti-bedsore cushion MULTILPLE Instant Perineal Cold Pack Clay Pack Cool Gel Mat(Pad) HOT OR COLD PACK REUSABLE Instant Perineal Hot Pack Instant cold pack Instant hot pack Disposable perineal cold pad Heat patch Cool compress patch Cold pack RITECARE Autoclave Bag ASP060, ASP061, ASP062, ASP063, ASP064, ASP065, ASP066, ASP067, ASP068, ASP069 RITECARE Stool Disposal Bag ASP087, ASP088, ASP089 RITECARE Medical Specimen Bag ASP081, ASP082, ASP083, ASP084 RITECARE Spill kit Bag ASP086 RITECARE Vomiting Bag ASP090 RITECARE Biohazard Bag ASP070, ASP071, ASP072, ASP073, ASP074, ASP075, ASP076, ASP077, ASP078, ASP079 universal brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2016-11-30
NTC	Nursing Pad, Hydrogel	General Hospital	Class 1	880.5630	2023-06-24
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2006-08-16
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2025-09-18
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2021-06-29
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2021-12-15
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2005-02-14
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2020-07-23
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2012-06-14

Official Correspondent

Yan He

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Shanghai Chuangshi Medical Technology (Group) 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-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005023997. Last updated year: 2026. Please use registration number 3005023997 when referencing this establishment in official correspondence.