Protective Cases for Medical Devices and Pharmaceutical

Is Kexin ISO 13485 certified for medical device cases?

Kexin production facility is ISO 9001:2015 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 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.