SHANGHAI CHENGSHENG INTERNATIONAL TRADING CO.,LTD

FDA Device Registration & Listing · Shanghai, CN · Registration 3023141635

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023141635
FEI Number
3023141635
Entity Name
SHANGHAI CHENGSHENG INTERNATIONAL TRADING CO.,LTD
City/State/Country
Shanghai, CN
Establishment Address
Room.H38, Building 7th, No.1391 West Weiqing Road, Jinshan District, Shanghai 201500, CN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Shanghai Chengsheng International Trading Co.,Ltd (Owner Number: 10085452)
Owner / Operator Contact Address
Room.H38, Building 7th, No.1391 West Weiqing Road, Jinshan District, Shanghai, CN-NOTA 201500, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Tape and bandage, adhesive Non-adherent Pad Drape, surgical, exempt Elastomer, silicone, for scar management Pack, hot or cold, disposable BANDAGE, ELASTIC Dressing, wound, occlusive

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2025-12-17
NAC Dressing, Wound, Hydrophilic General, Plastic Surgery Class 1 878.4018 2024-01-11
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2024-08-20
MDA Elastomer, Silicone, For Scar Management General, Plastic Surgery Class 1 878.4025 2025-12-17
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2025-12-17
FQM Bandage, Elastic General Hospital Class 1 880.5075 2025-12-17
NAD Dressing, Wound, Occlusive General, Plastic Surgery Class 1 878.4020 2025-12-17

Official Correspondent

Ellen Chen

US Agent Details

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

Related Public Records

Same Entity

Shanghai Chengsheng International Trading 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
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
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
Z-0013-2019 COVIDIEN LLC 1
Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019 COVIDIEN LLC 1
Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019 COVIDIEN LLC 1
Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023141635. Last updated year: 2026. Please use registration number 3023141635 when referencing this establishment in official correspondence.
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