09-Nov--2026Private-label medical disposables look simple — your logo on the pouch, your name on the carton. Under EU MDR and US FDA rules, if you place a device under your own brand, you're the legal manufacturer. The technical file, Declaration of Conformity, and UDI registration stay with you. |  |
 | What to require from your OEM partner: · Process validation and accredited test reports · Written change-control clause · Signed sample approval against written specs · Regulatory documentation delivered before first shipment
Bestex — Your OEM/ODM Partner Since 1999 Qingdao Bestex Rubber & Plastic Products Co., Ltd. focuses on Class I & Class II disposable medical and PPE products: face masks, face shields, protective apparel, dental bibs. ISO 13485 certified; CE and FDA 510(k) clearance available on applicable lines. Workshop capacity up to 40M+ pieces/year. Exported to US, EU, Japan, Korea, and Southeast Asia. We support private-label brands with multi-language labeling, market-specific compliance docs, and full export documentation. Start with one SKU, one market, one trial order. |
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Disclaimer: For general sourcing and industry information only. Not medical advice. Compliance must be confirmed per market and model.
