FAQ

Yes. Our core product lines - transparent dressings,non woven wound dressings, catheter fixation devices, disposable nursing kits, medical foam dressings and surgical dapes - are CE marked. We monitor the EU MDR transition timeline closely (including the extended deadline for legacy devices in December 2027) and provide the Declaration of Conformity (DoC), technical documentation and clinical evaluation support to our EU distributors and importers. Updated certificates and the full regulatory dossier are available on request before you place an order.

Yes. Our manufacturing facility is registered with the U.S. FDA, and our medical consumables are listed in the FDA registration database as required. Most of our products are Class I or Class II exempt devices, so no 510(k) pre-market notification is required for standard items. We supply our FDA establishment registration number and product listing details with every shipment document package, and we can support 510(k) submission for specialized custom devices if your project requires it.

Yes. We have maintained ISO 13485:2016 certification (issued by an accredited notified body such as TÜV) since our early years of operation, covering the design and manufacture of disposable medical consumables. The current certificate, scope statement and the latest surveillance audit summary can be shared under NDA. We also welcome on-site audits, third-party inspections (SGS, TÜV, BV) and virtual factory tours via live video walkthrough of our cleanroom workshops.

All of our wound dressings, fixation devices and tapes are latex-free. Raw materials are skin-friendly polyurethane films, non-woven fabrics and medical-grade acrylic adhesives.

Yes. We support UDI compliance for both the EU MDR (Basic UDI-DI + UDI-DI on labels and, where applicable, direct part marking) and the U.S. FDA rule under 21 CFR Part 830. We can print UDI carrier codes (GS1 DataMatrix) on primary packaging, provide UDI data in the required format (EUDAMED / GUDID fields), and register the UDI information under either our name or your private label name depending on the OEM structure agreed.

Yes, OEM/ODM is one of our core services. As a manufacturer with our own coating, die-cutting and cleanroom assembly lines, we offer a one-stop service covering structural design, material selection, mold and tooling, printing, sterile packaging and mass production. You can use your own brand, logo and artwork on both products and cartons. Over the years we have served distributors, hospital group purchasing organizations and private-label brands across Europe, Africa, the Middle East,South America and Southeast Asia.

Absolutely. Customization of disposable care kits is one of our strengths - Dialysis On/Off kits, IV Start Kits, Basic Dressing Kits and Blood Collection Trays can all be adjusted in components, tray layout, drape and packaging. You provide the component list and sequence-of-use layout; our engineering team will confirm feasibility, optimize the tray design for one-handed access, and provide a sample kit for clinical review within approximately one-two weeks.

For custom printed pouches, folding cartons and labels, tooling cost depends on the number of colors, print size and process (flexo or gravure). A typical single-color flexo plate starts from a low setup fee, while full-color gravure cylinders cost more but amortize well at volume. Sampling normally takes 10-15 working days after artwork approval. Exact tooling quotations are issued with your specification sheet, and tooling fees are commonly waived or refunded once cumulative order quantities reach agreed thresholds.

Yes - performance benchmarking against leading brands is a routine part of our OEM projects. Our transparent PU film dressings deliver comparable waterproofness, breathability (MVTR), adhesion level and wear time, and our catheter securement devices provide equivalent holding strength and skin-friendly removal. We provide side-by-side specification comparison sheets and encourage benchmark testing with free samples before you commit to volume. Please note all brand names referenced belong to their respective owners and are used here only to indicate the intended performance class.

Yes. With in-house die-cutting capability we produce dressings in any custom shape and size - from standard squares and rectangles to wound-specific contoured shapes for joints, sacrum and heel. Common customizations include frame-delivery systems, centrals with non-adherent pads, and custom perforation patterns. Custom sizes typically carry a slightly higher MOQ than standard SKUs; a die-cutting sample can be ready in 5–8 Business days for your confirmation.

For our existing standard SKUs, the MOQ is very friendly - typically one export carton per item, so you can consolidate a full container with dozens of SKUs to test your market. For OEM/private-label orders, MOQ depends on the product and customization level: printed pouches usually start around 10,000 pcs per design, custom kits around 3,000–5,000 sets, and standard unprinted items can be much lower. We always quote the exact MOQ per line item in the formal quotation.

Yes. Free samples of our existing products are available - we can dispatch within 3–5 working days by DHL/UPS/FedEx with freight collected, or send them together with your next order free of freight. For customized samples (your logo or design), we charge a modest sampling and tooling fee, which is fully credited back once the bulk order is confirmed. Sampling is the fastest way for your clinical or quality team to verify material, adhesion and packaging before committing.

Standard terms are 30% T/T deposit with the 70% balance against the copy of the bill of lading. For long-term partners and repeat orders we offer more flexible arrangements. Online trade-assurance orders and other secure channels can also be arranged for first-time cooperation. All commercial terms are confirmed in the PI (Proforma Invoice) before production starts.

We support EXW, FOB (Qingdao or Shanghai), CIF and CFR to major ports, and DAP/DDP door delivery to most destinations for qualified orders. Sea freight from Qingdao to Los Angeles takes roughly 20–25 days and to European base ports around 35–40 days; air freight and express courier are available for urgent or sample shipments. We can also consolidate multiple SKUs into mixed containers to maximize your container utilization.

Our quotations are valid for 30 days under normal market conditions. For key raw materials (PU film, non-woven fabric, medical adhesive), we maintain strategic stock and long-term supplier contracts to smooth out short-term fluctuations. For annual contract customers we offer fixed-price windows per quarter and transparent cost breakdowns, so you can plan your import costing reliably. If a significant market shift occurs, we always communicate proactively before accepting a new order.

Packing list, Commercial invoice and related COO.

About have a tariff of 15% than before, a little influence.

Our main loading ports are Qingdao Port. Take a example, only need 30 days to USA.

Yes. We support FBA Terms. We have couriers supporting FBA goods.

Yes. We have MDR based CE certificate. Can provide related document to support it.

Our transparent dressings use a medical-grade polyurethane film coated with a hypoallergenic acrylic adhesive. The film is waterproof (showering allowed) while allowing moisture vapor transmission so the skin underneath stays healthy

Our catheter securement devices combine a strong but skin-friendly adhesive baseplate with an engineered locking mechanism that grips the catheter hub without pinching the lumen. In use, they limit catheter micro-motion and migration far better than tape alone, which is a recognized factor in catheter-related complications and unplanned extubation.

Choose by exudate level. Foam dressings absorb large amounts of exudate while maintaining a moist wound bed, making them ideal for moderately to heavily exuding wounds such as pressure injuries and post-operative wounds; silicone-face foams minimize trauma on fragile skin at every change. Hydrocolloid dressings interact with wound fluid to form a gel, supporting autolytic debridement for low-to-medium exudate wounds like superficial pressure sores and minor burns, and can stay in place for several days. We manufacture both and can recommend the right dressing by wound type.

Yes - kit configuration is fully adjustable.
Dialysis on/off kits, IV start kits, PICC Maintenance kits and dressing change kits each have a standard component list, but Adjustments will be made based on Different department.: adding or removing gloves, drapes, syringes, swabs or chlorhexidine items, adjusting tray layout for left/right-hand workflow, and printing usage-sequence inserts for nursing staff. This cuts preparation time at the bedside and reduces per-procedure waste for the hospital.

Yes. Our maternal & baby line - baby umbilical cord care patches, navel protection stickers and postpartum belly bands - is designed specifically for newborn and postpartum skin. Adhesives are low-sensitization medical-grade formulations tested per ISO 10993, materials are soft, breathable and latex-free, and the umbilical patches keep the cord area dry and protected during bathing. We supply the full biocompatibility and skin-safety test package to support registration in your market.