Frequently Asked Questions

Everything you need to know before getting started.

Q

What product categories do you offer?

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We supply five certified product lines: Health Monitoring (blood pressure monitors, pulse oximeters), Scar Management (silicone gel and sheets), Compression Therapy (stockings, anti-embolism socks, air compression massagers), Wound Care (Silicone foam dressings, hydrocolloid dressings, anti-decubitus mattresses), and Respiratory Health (compressor and mesh nebulizers). All products are manufactured in ISO 13485-certified facilities with CE MDR and FDA 510(k) clearances where applicable.

Q

What certifications do your products hold?

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Our products and manufacturing partners maintain ISO 13485:2016 certification for quality management systems, CE marking under MDR 2017/745 (with Notified Body involvement for higher-risk devices), and FDA 510(k) clearances for applicable product categories. We also support additional country-specific certifications as required by your target market — SFDA (Saudi Arabia), TGA (Australia), ANVISA (Brazil), and others are available upon request.

Q

What is your Minimum Order Quantity (MOQ)?

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We operate a highly flexible production system. There is no rigid MOQ — we welcome mixed SKUs, mixed container loads, and small trial orders. Please note that per-unit pricing for smaller quantities will be higher than for larger volume orders. We are happy to discuss your specific needs and find a workable solution.

Q

Do you support OEM / Private Label?

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Yes — this is a core part of our business. We offer full OEM and private label services: product appearance customization (color, logo, packaging), formulation customization (e.g., scar gels with added vitamins or UV protection), and specification customization (e.g., scar sheet thickness, dressing sizes). The same production lines that serve leading global brands are available for your brand — without the brand markup.

Q

How do you ensure product quality?

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Quality is built into every step of our process:

Supplier auditing — every partner factory is on-site audited and ISO 13485-certified

In-line checks — automated inspection during production

100% pre-shipment inspection — every batch is inspected before it leaves the factory

Traceability — raw material to finished goods, traceable within 24 hours

Our defect rate is consistently below 0.25% based on pre-shipment inspection data. We believe in quality control with numbers, not adjectives.

Q

Do you provide regulatory documentation for market entry?

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Absolutely. Every shipment ships with Certificate of Analysis (CoA), packing list, Bill of Lading, and Country of Origin certificate. For regulatory submissions, we provide CE technical files, FDA 510(k) supporting documentation, biocompatibility test summaries, and country-specific registration assistance. Our goal is to make your market entry as smooth as possible.

Q

What is your typical lead time?

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Lead time depends on the product and order size. For standard products, samples typically take about 7 days; mass production orders generally ship within 20-30 days after deposit confirmation and final product approval. For urgent hospital projects, we can prioritize production with an expedited timeline — please contact our sales team to discuss your specific deadline and requirements.

Q

What are your shipping terms?

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We are flexible. Our standard terms are FOB from Chinese ports, but we also support CIF, DDP, and door-to-door delivery. Sea, air, and land freight are all available. We handle cargo insurance, customs documentation, and logistics coordination — making sure your products arrive safely and on time.

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We know every market and every partner is different. If you don’t see your question here, ask us directly — we‘ll get back to you within 24 hours.