FDA-approved protective case: Aperçu
FDA-approved protective cases (Food and Drug Administration) for medical devices and pharma logistics. Materials FDA-compliant per 21 CFR 177.1520 (PP), 21 CFR 177.1580 (PC), 21 CFR 177.1640 (PS). USP Class VI biocompatibility optional (USD 500-1,200 per SKU test). ISO 13485 certified production. Cleanroom final assembly Class 8 (ISO 14644-1, formerly 100,000) available (+USD 1.50/box packaging). IQ/OQ/PQ validation documentation for FDA submission. ETO sterilization compatible (ethylene oxide 100% material compatible). FDA Master File Access Letter for FDA-registered customers. Applications: mobile X-ray, defibrillators, hemodialysis, infusion pumps.
Spécifications
| المادة | PP / ABS / PC / Aluminium |
|---|---|
| مدة الإنتاج | 30–45 jours |
| الحد الأدنى للكمية | 500 pièces |
| المصدر | Guangdong, Chine |
| الشهادات | CE / RoHS / REACH / ISO 9001 / BSCI |
المميزات
- Étanche IP67/IP68 poussière et eau (IP68 en option jusqu'à 5 m)
- Résistance aux chutes et chocs MIL-STD-810H, 26+ chutes de 1,2 m
- Insert mousse découpé CNC sur mesure pour votre appareil
- Couleur Pantone dès 500 pièces MOQ
- Serrure TSA, valve d'équilibrage, joint torique
- EXW Guangdong ou FOB Shenzhen / Ningbo, 30–45 jours de délai
التطبيقات
La FDA-approved protective case est utilisée dans de nombreuses industries : industriel, photo, drone, défense, médical, secours, radio, arpentage, marine et plus. La personnalisation OEM/ODM est standard.
الأسئلة الشائعة
What is the minimum order quantity (MOQ)?
Standard MOQ 500 pieces for OEM Pantone colour and custom logo. Standard colours and hot-stamp logo from 100 pieces. Custom solutions from 1000 pieces for best unit price.
What is the lead time?
Standard lead time 30–45 days after artwork approval for OEM/ODM. Sample production 7–10 days. EXW Guangdong factory or FOB Shenzhen / Ningbo port. B2B only.
Which certificates and standards do the cases meet?
CE, RoHS 2/3 (EU 2015/863), REACH (EC 1907/2006), ISO 9001:2015, BSCI certified. On request: IP67/IP68 test reports per IEC 60529, MIL-STD-810H drop test, ATA 300 air transport tests. Each shipment includes compliance documentation.
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