Series · 8-series Premium Use case · Medical Devices IP68

8-series premium cases for medical devices

8-series premium protective cases for medical OEMs and hospitals. FDA-compliant cleaning (21 CFR 177.1520), ISO 8 cleanroom final assembly (Class 100,000), USP Class VI biocompatibility optional, IQ/OQ/PQ documentation included. Applications: mobile X-ray (GE Optima XR240, Philips Practix, Siemens Mobilett), portable ultrasound (GE Vscan, Philips Lumify, Butterfly iQ), defibrillators (Philips HeartStart FRx, ZOLL AED Plus), hemodialysis devices, infusion pumps, COVID-19 test kits. 8-series with ESD protection optional. AQL 1.0 for medical orders. EXW Guangdong or FOB Shenzhen / Ningbo.

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Technical highlights

Series: 8-series Premium
Use case: Medical Devices
IP-Rating: IP68
Material: PP / ABS / Aluminum / HD-PE (series-dependent)
Foam: CNC foam inlay (custom) or pick-and-pluck
Delivery: EXW Guangdong / FOB Shenzhen / Ningbo
MOQ: 500 pieces per Pantone color

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Frequently asked questions

What FDA documentation comes with each 8-series medical case order?

Each 8-series medical case order includes: (1) Certificate of Conformance per lot, (2) Material Certificates (FDA 21 CFR 177.1520 for PP), (3) USP Class VI biocompatibility test reports (where applicable), (4) ISO 8 cleanroom assembly certificate, (5) IQ/OQ/PQ protocols, (6) FDA Material Master File access letter for FDA-registered customers, (7) BSE/TSE free statement.

Is your production ISO 13485 certified?

Yes, Kexin production facility is ISO 9001:2015 certified and ISO 13485 certified (Medical Device QMS) since 2018. We provide Declaration of Conformity, FDA Material Master File access, and biocompatibility reports for materials in patient-contact devices. USP Class VI testing available on request.

What is the lead time for 1000 medical cases with custom foam?

Sample 7-10 days. Bulk 1000 pieces 30-45 days after artwork + foam DXF approval. Foam production adds 5-7 days. ISO 8 cleanroom assembly adds 2-3 days. Total 35-55 days. Shipping 25-30 days by sea to EU/US. T/T 30/70 or L/C at sight.

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Get a free quote and reply within 24 hours on business days. 500-piece MOQ.

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