# Protective Cases for Medical Devices and… > FDA-compliant, ISO 8 cleanroom assembly, IQ/OQ/PQ documentation — Kexin cases for medical devices and pharma logistics. Human-readable page: https://oembox.beeaa.com/en/industries/medical/ Site overview for AI agents: https://oembox.beeaa.com/llms.txt ## Page content Kexin protective cases for medical devices and pharmaceutical meet FDA requirements (21 CFR Part 820 Quality System Regulation) and ISO 13485 medical device quality management. Optional ISO 8 cleanroom final assembly (Class 100,000 particles/m³). IQ/OQ/PQ documentation (Installation, Operational, and Performance Qualification) included. Material certificates FDA 21 CFR compliant, USP Class VI biocompatibility optional. Applications: medical devices, diagnostics, pharma logistics (controlled temperature 2-8°C), dental, veterinary, emergency medicine, EMS, sample collection, hemodialysis devices, infusion pumps, mobile X-ray. 8-series and Trolley for mobile medical care, vaccine distribution, disaster relief. [Request a quote](https://oembox.beeaa.com/en/contact/) [OEM / ODM](https://oembox.beeaa.com/en/oem/) Industries · medical ## 5 Key Takeaways: Protective Cases for Industry 1. Industry: Industry – custom protective case solutions 2. Applications: protection of tools, instruments, devices, spare parts and components 3. Material: PP / ABS / Aluminum / HD-PE, IP54–IP68, CNC foam inlay or pick-and-pluck 4. Order: MOQ 500 pieces per Pantone color, 30–45 days lead time, CE/RoHS/REACH/ISO 9001/BSCI 5. Shipping: EXW Guangdong (pickup) or FOB Shenzhen / Ningbo (sea freight). 28–35 days to Hamburg / Rotterdam ## Recommended series [8-series Premium](https://oembox.beeaa.com/en/products/series/premium/)[Trolley series](https://oembox.beeaa.com/en/products/series/trolley/) ## Frequently asked questions Is Kexin ISO 13485 certified for medical device cases? Kexin production facility is [ISO 9001:2015](https://oembox.beeaa.com/en/keywords/china-case-factory/) certified (Quality Management) and ISO 13485 certified (Medical Device QMS) since 2018. The medical device line operates under FDA 21 CFR Part 820 Quality System Regulation. We provide Declaration of Conformity, FDA Material Master File access (where applicable), and biocompatibility reports for materials in contact with patient-contact devices. Can Kexin cases maintain 2-8°C cold chain for vaccine transport? Yes, with PCM (Phase Change Material) cold packs or VIP (Vacuum Insulation Panel) inserts. Kexin cases are validated for cold chain transport with 72+ hour temperature hold at 2-8°C using appropriate gel/PCM packs. Trolley series with VIP-lined foam insert achieves 96+ hours. WHO PQS (Performance, Quality, Safety) and UNICEF supply chain compliance documentation available for vaccine distribution programs. What FDA documentation comes with medical cases? Each medical case order includes: (1) Certificate of Conformance, (2) Material Certificates (FDA 21 CFR 177.1520 for PP), (3) USP Class VI biocompatibility test reports (where applicable), (4) ISO 8 cleanroom final assembly certificate (if option selected), (5) IQ/OQ/PQ protocols and reports, (6) FDA Material Master File access letter (for FDA-registered customers), (7) BSE/TSE free statement for animal-derived material concerns. Do you make cases for mobile X-ray or ultrasound devices? Yes. Trolley series with custom foam is our standard recommendation for mobile X-ray (GE Optima XR240, Philips Practix, Siemens Mobilett) and portable ultrasound (GE Vscan, Philips Lumify, Butterfly iQ). Foam density 35kg/m³ with shock-absorbing base layer. Anti-static (ESD) foam optional. Lead-lined case variants for radiation shielding accessories. 500-piece [MOQ](https://oembox.beeaa.com/en/keywords/oem-protective-case/) per Pantone color and logo. What is the lead time for 1000 medical cases with custom foam? Sample 7-10 days. Bulk 1000 pieces 30-45 days after artwork and foam DXF approval. Foam production adds 5-7 days to standard case production. ISO 8 cleanroom final assembly adds 2-3 days. Total 35-55 days for full custom production. Shipping 25-30 days by sea to EU/US. Air freight 5-10 days. T/T 30/70 standard or L/C at sight for large orders. ## Related content ### Top regions for this industry [🇺🇸 Protective cases for North America (USA/Canada/Mexico) ATA 300 + MIL-STD for US market. FOB Long Beach / Vancouver.](https://oembox.beeaa.com/en/regions/north-america/)[🇪🇺 Protective cases for Western Europe (FR/IT/ES/NL/BE) French + Italian + Spanish multilingual support. FOB Marseille / Genoa.](https://oembox.beeaa.com/en/regions/western-europe/)[🌏 Protective cases for Asia-Pacific (JP/KR/SG/AU/NZ/IN) Japanese + Korean + English language support. FOB Yokohama / Busan / Singapore.](https://oembox.beeaa.com/en/regions/asia-pacific/)[🕌 Protective cases for Middle East / GCC (SA/UAE/QA/KW/BH/OM) Direct shipping to Saudi Arabia, UAE, Qatar, Kuwait, Bahrain, Oman. FOB Shenzhen or Ningbo + 18-28 days sea freight via Dammam/Jeddah/Dubai.](https://oembox.beeaa.com/en/regions/middle-east/) ### Popular keywords - [Medical Case](https://oembox.beeaa.com/en/keywords/medical-case/) - [Tactical Medical Case](https://oembox.beeaa.com/en/keywords/tactical-medical-case/) - [Military Medical Case](https://oembox.beeaa.com/en/keywords/military-medical-case/) - [Small Medical Case](https://oembox.beeaa.com/en/keywords/small-medical-case/) ### Model comparisons for this industry [WL8-3815 vs WL8-4430 WL8-3815 vs WL8-4430 – Premium PP Case Comparison | Kexin OEM](https://oembox.beeaa.com/en/comparisons/wl8-3815-vs-wl8-4430/)[WL8-5023 vs WL9-5419 WL8-5023 vs WL9-5419 – PP vs ABS Case Comparison | Kexin OEM](https://oembox.beeaa.com/en/comparisons/wl8-5023-vs-wl9-5419/)[WL8-5023 vs WL8-5823 WL8-5023 vs WL8-5823 – Which case fits your application? | Kexin](https://oembox.beeaa.com/en/comparisons/wl8-5023-vs-wl8-5823/)[WL606B vs WL2808 WL606B vs WL2808 – Aluminium HD vs PP Entry Ruggedness | Kexin OEM](https://oembox.beeaa.com/en/comparisons/wl606b-vs-wl2808/)[WL4321 vs WL606B WL4321 vs WL606B – PP Entry Large vs Aluminium HD Compact | Kexin OEM](https://oembox.beeaa.com/en/comparisons/wl4321-vs-wl606b/)[WL6-3917 vs WL8-3815 WL6-3917 vs WL8-3815 – ABS IP67 vs Aluminium IP68 | Kexin OEM](https://oembox.beeaa.com/en/comparisons/wl6-3917-vs-wl8-3815/) ## Request a quote Get a free quote and reply within 24 hours on business days. 500-piece MOQ. 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