FDA 21 CFR 177.2600 | CE / RoHS 2.0 / UN38.3 Certified | Dongguan Hengli 3,500 mยฒ Direct OEM/ODM Plant
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ISO/IEC 15459 & EU ESPR (2024/1781) Validated

Smart Biofeedback Bluetooth Kegel Balls

Universal SKU: YQ-KG01 | Enterprise Node: 100018 | Authority: ZGC Code Center

๐ŸŒ Digital Object Identity & Universal Registry
ISO/IEC 15459 Universal Object Code
MA.156.100018.01.YQ-KG01
Official MA Hierarchy Code (ZGC / Mafulink)
MA.15602.315.1038/10.14013000.YQ-KG01
Cryptographic SHA-256 Ledger Hash (Immutable Proof)
00BCD113CC8DFECA1ECC3DB4A144231D โœ“ LEDGER MATCH
๐Ÿงช Material Safety & Chemical Composition (BOM)
Polymer / Elastomer Specification
Medical-Grade Platinum Silicone + Medical Stainless Steel Counterweights
Durometer & Texture Profile
Shore A 38
Waterproof Rating & Hermeticity
IPX7 100% Submersible Waterproof
Power & Electromechanical System
Inductive Wireless Qi Fast Charging, Pressure Biofeedback Sensors
Chemical Safety & Toxicological Benchmark
100% Phthalate-free (16P Free), Bisphenol A (BPA) non-detectable (<0.01mg/kg), Lead & Cadmium zero migration under RoHS 2.0. Compliant with REACH SVHC candidate list (240 substances <0.1% w/w).
โ™ป๏ธ EU ESPR Ecodesign & End-of-Life Disassembly
Circularity & Recyclability Grade
Grade A
Municipal Sorting Code
SPI Code 7 (Technical Liquid Silicone Composite)
Disassembly Protocol (EU ESPR 2024/1781 Tool-Free Requirement)

Monolithic liquid silicone molded retrieval cord tested to >60N tensile strength.

๐Ÿ›๏ธ Third-Party Authority Certifications & Testing Evidence
Authoritative Test Reports
FDA 21 CFR 177.2600, CE-EMC, RoHS 2.0, BLE 5.0
Manufacturing Facility Qualification
ISO 9001:2015 Certified | Class 100,000 Cleanroom
Country of Origin & Plant
Dongguan, Guangdong, China (YAQU Medical Silicone Hengli Plant)
Customs Tariff Harmonized Code (HS)
HS 9019.10.90 / 3926.90.97
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