Wenzhou Shengkai Technology Industry Co.,Ltd

FDA Device Registration & Listing · Wenzhou city Zhejiang, CN · Registration 3016861904

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
3016861904
FEI Number
3016861904
Entity Name
Wenzhou Shengkai Technology Industry Co.,Ltd
City/State/Country
Wenzhou city Zhejiang, CN
Establishment Address
No.2 Hongye Road, Cangnan Jinxiang town, Wenzhou city Zhejiang 325805, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Wenzhou Shengkai Technology Industry Co.,Ltd (Owner Number: 10065226)
Owner / Operator Contact Address
No.2 Hongye Road, Cangnan Jinxiang town, Wenzhou city, CN-ZJ 325805, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Tactical Tourniquet, tourniquet First aid kit Compress/pack, heat pack, ice pack Face mask, Disposable face mask, Face shield, life Hammer, emergency tent Cooling gel sheet Protective clothing, Disposable isolation suit Emergency blanket,Emergency sleeping bag,Emergency bivvy,Emergency tube tent Emergency poncho Goggles Self adhesive elastic bandage/PBT Elastic Bandage, triangular bandage Tactical Bandage, elastic bandage Wet wipes/Wet tissue, Cleansing wipes,Disposable cleaning prep pad, Lens wipes, Lens cleaning wipes,Glasses wet wipes, Antibacterial delay wet wipes, Delay spray wipes Glasses cleaning tissue,Optical lens wipes, Camera lens wipes Sterile wet wipes, Adult delay wipes, Sex delay wipes,Adults cleaning wipes Screen clean wipes, Disinfection wipes, Isopropyl alcohol wipes Swabs, Swab sticks (Povidone Iodine swabs, Alcohol swabs, Saline swabs), Cleaning Spray Saline, Disinfectant (Saline Solution, Cleaning Solution); Saline, Pad (Saline pads, Saline wipes);

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2023-09-12
OHO First Aid Kit Without Drug General, Plastic Surgery Class 1 878.4014 2020-03-28
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2023-09-12
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-03-28
OMW Adhesive Backed Thermal Skin Patches Physical Medicine Class 1 890.5710 2023-09-12
OEA Non-Surgical Gown General, Plastic Surgery Class 1 878.4040 2020-03-28
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2020-03-28
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2020-03-28
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2023-09-12
FQM Bandage, Elastic General Hospital Class 1 880.5075 2023-09-12
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2020-03-28

Official Correspondent

Dejia zhang

US Agent Details

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

Related Public Records

Same Entity

Wenzhou Shengkai Technology 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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016861904. Last updated year: 2026. Please use registration number 3016861904 when referencing this establishment in official correspondence.
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