Medical Protective Case Source Factory | Cold-Chain & Diagnostic

Medical-grade protective cases for cold-chain pharmaceutical transport, diagnostic kits, EMS response, and sterilizable-instrument storage. Maintains 2-8 C for up to 96 hours with phase-change ice packs (validated ISTA 7E). ISO 13485 quality system, FDA-grade materials, IP67. Tamper-evident seals for chain-of-custody. OEM/ODM custom foam inserts. FOB Shenzhen / FOB Ningbo / EXW. B2B export only.

Medical Case Manufacturer | Cold-Chain & Diagnostic OEM/ODM
ISO 9001:2015
Quality Management
IP67/IP68
Ingress Protection
CE / ROHS / REACH
EU Compliance
MIL-STD-810G
Subset (Drone/Defense SKUs)

Technical Specifications

Specifications for KeXinMaterials Medical series. OEM/ODM options available — inquire kexin@beeaa.com.
MaterialMedical-grade ABS + PP shell, anti-microbial additive
Protection RatingIP67, sealed against body-fluid ingress
Drop Test1.5 m onto concrete (ASTM D4169)
Operating Temperature -20 C to +40 C (cold-chain compatible)
ClosureLatches with tamper-evident security seals
InsulationOptional EPS insulated insert for cold-chain (2-8 C)
Internal Sizes50+ sizes handheld diagnostic to 50L cold-chain
Color OptionsWhite, Medical Green, OEM (>= 500 pcs)
CertificationsISO 9001, ISO 13485 (select models), ROHS, CE, IP67, FDA-grade
MOQ100 pcs (stock) / 500 pcs (custom insert / OEM)

Frequently Asked Questions

How long does the cold-chain version maintain 2-8 C?

Cold-chain insert maintains 2-8 C for up to 96 hours under ISTA 7E summer profile (32 C ambient, 50% RH) when pre-conditioned at -20 C for 24 hours and loaded with phase-change ice packs. For longer missions, we offer refrigerated +2-8 C powered inserts (12V/24V) that maintain temperature indefinitely with vehicle power.

Is the case material FDA-grade / biocompatible?

Yes. The shell and foam inserts are made from FDA 21 CFR Part 177 (food contact) compliant polymers, with anti-microbial additive. Cytotoxicity (ISO 10993-5) and sensitisation (ISO 10993-10) test reports available on request for select SKUs.

Do you support GMP-cleanroom packaging?

Yes - select SKUs ship double-bagged in ISO Class 7 (Class 10,000) cleanroom with vacuum-sealed inner PE bag. Cleanroom packaging fee: +5% MOQ >= 100 pcs. Required for pharmaceutical and medical-device OEMs with GMP audit requirements.

How long for export delivery and what are the trade terms?

Production 30-45 days after deposit. Sea freight FOB Shenzhen / FOB Ningbo: 25-40 days. Air freight 5-7 days. Express (DHL/FedEx) 3-5 days for samples. T/T 30% deposit, 70% balance before shipment. Buyer arranges own freight forwarder and import duties. We do NOT offer DDP.