FDA 21 CFR 177.2600 | CE / RoHS 2.0 / UN38.3 Certified | Dongguan Hengli 3,500 m² Direct OEM/ODM Plant
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ISO/IEC 15459 & EU ESPR (2024/1781) Validated

350ml Anti-Backflow Medical Silicone Enema Bulb

Universal SKU: YQ-AD04 | Enterprise Node: 100018 | Authority: ZGC Code Center

🌐 Digital Object Identity & Universal Registry
ISO/IEC 15459 Universal Object Code
MA.156.100018.01.YQ-AD04
Official MA Hierarchy Code (ZGC / Mafulink)
MA.15602.315.1038/10.14013000.YQ-AD04
Cryptographic SHA-256 Ledger Hash (Immutable Proof)
0DE57A4D2C180D22FC63017D71037713 ✓ LEDGER MATCH
🧪 Material Safety & Chemical Composition (BOM)
Polymer / Elastomer Specification
100% FDA Medical-Grade Liquid Silicone Rubber (Shore A 45) + Food-Grade PP Nozzle
Durometer & Texture Profile
Shore A 45 (High Recovery Resilience)
Waterproof Rating & Hermeticity
100% Watertight Leakproof / 121°C Autoclavable Sterilization
Power & Electromechanical System
Non-Electric / Hydrodynamic Manual Squeeze Recovery
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).
♻️ EU ESPR Ecodesign & End-of-Life Disassembly
Circularity & Recyclability Grade
Grade A (100% Pure Silicone Oil Depolymerization)
Municipal Sorting Code
SPI Code 7 (Technical Liquid Silicone Composite)
Disassembly Protocol (EU ESPR 2024/1781 Tool-Free Requirement)

100% Mechanical tool-free threaded nozzle separation. Removable medical duckbill anti-backflow valve.

🏛️ Third-Party Authority Certifications & Testing Evidence
Authoritative Test Reports
FDA 21 CFR 177.2600, LFGB Section 30/31, RoHS 2.0, ISO 10993 Cytotoxicity Free
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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© 2026 Dongguan Yaqu Silicone Products Co., Ltd. | Official MA-DPP Digital Product Passport Gateway | Compliant with ISO/IEC 15459 & EU ESPR 2024/1781.