Compliance & Certifications
Ningbo Shangcun Electronic Co., Ltd. is listed in the FDA Establishment Registration & Device Listing database for Clinical Electronic Thermometers, Product Code SDV, Device Class II, Regulation No. 880.2910.
Our infrared forehead thermometer models FI01, FI02, FI03, FI04, FI05 and FI06 have been tested according to IEC/EN 60601-1 and IEC/EN 60601-1-11 standards.
FDA Establishment Registration & Device Listing
Registered Establishment: NINGBO SHANGCUN ELECTRONIC CO., LTD.
Owner/Operator No.: 10094620
Product Code: SDV
Device Class: II
Regulation No.: 880.2910
IEC/EN 60601-1 Test Report
Product: Infrared Forehead Thermometer
Models: FI01, FI02, FI03, FI04, FI05, FI06
Report No.: CHTM26015100
Issue Date: January 16, 2026
Testing Laboratory: Shenzhen Huatongwei International Inspection Co., Ltd.
IEC/EN 60601-1-11 Test Report
Product: Infrared Forehead Thermometer
Models: FI01, FI02, FI03, FI04, FI05, FI06
Report No.: CHTM26015099
Issue Date: January 16, 2026
Testing Laboratory: Shenzhen Huatongwei International Inspection Co., Ltd.
U.S. Agent Information
U.S. Agent: Easyinsmile(USA) International Corp
Address: 90 Dayton Ave Bldg Sd Fl 4, Passaic, NJ 07055, USA
Agreement Valid Until: September 30, 2026
Download U.S. Agent Agreement 2
Download U.S. Agent Agreement 3
Note: FDA establishment registration and device listing does not denote FDA approval. Documents are provided for regulatory and product compliance reference.