Can you help with FDA registration? Yes. We provide complete technical documentation to support our importers in completing FDA registration and listing for the US market. Key points: 1. Full technical files - Device description, labeling and specification documents. 2. Listing support - We guide the importer through FDA establishment registration and device listing. 3. US market ready ...

How do you deliver test reports to customers? We provide stamped PDF electronic copies, original third-party laboratory reports and official certificate verification links. Paper copies can be shipped together with your bulk order or sent separately by courier. Key points: 1. PDF electronic copy - Stamped digital reports sent by email immediately. 2. Original reports - Original third-part...

Can you quickly expand capacity when orders surge, without raising prices? Yes. With multiple production lines we can temporarily expand capacity by 30%-50%, and our prices remain stable during peak periods. Key points: 1. Multiple lines - Independent lines for bags, cases, bandages and consumables. 2. 30-50% expansion - Temporary capacity increase for urgent or large orders. 3. Stable ...

How do you manage batch and expiry dates? We adopt a first-in-first-out (FIFO) system. Every batch has a unique batch code, and expiry dates are managed and traceable throughout the entire process. Key points: 1. FIFO rotation - First-in-first-out stock rotation prevents expired consumables. 2. Unique batch code - Every batch is coded and traceable from material to shipment. 3. Expiry c...

Are your raw materials traceable? Do you have a stable supply chain? All dressings and consumables come from qualified suppliers. Every batch is traceable, the supply chain is stable, and we keep safety stock to protect your lead times. Key points: 1. Qualified suppliers - All materials are sourced from audited, qualified suppliers. 2. Batch traceability - Every batch carries a unique cod...

Do you use ERP to manage orders? Yes. We manage all orders through an ERP system with full-process tracking, so production, quality inspection and shipment status are transparent and verifiable at any time. Key points: 1. Full tracking - Every order is tracked from placement to shipment. 2. Transparency - Production and QC milestones are visible to the sales team in real time. 3. Tracea...

Do you have quality control? What is your QC process? Yes. Our full-process QC covers: incoming raw material inspection, production monitoring, finished product sampling, expiry date management and final inspection before shipment. Key points: 1. Incoming inspection - All raw materials are checked against qualified supplier standards. 2. Production monitoring - In-line quality checks duri...

Do the consumables in your first aid kits have an expiry date? Yes. Our consumables typically have a 5-year validity, and every shipment leaves with at least 24 months of remaining shelf life. Key points: 1. 5-year validity - Standard shelf life of the consumables in our kits. 2. 24-month guarantee - Minimum remaining shelf life at delivery is 24 months. 3. Expiry management - FIFO stoc...

What do the common components in a first aid kit do? Sterile dressing: sterilized covering for wounds. Elastic bandage: compression hemostasis and fixation. Tourniquet: severe bleeding control. Burn dressing: cooling, pain relief and anti-infection. Alcohol prep pad: one-time skin disinfection. Key points: 1. Sterile dressing - Sterilized wound coverage to prevent contamination. 2. Elasti...

What is the difference between car, home and pet first aid kits? Home kits: lightweight and comprehensive, focused on daily bumps and cuts. Car kits: high-temperature resistant and shock-proof, plus traffic safety tools. Pet kits: alcohol-free non-irritating supplies with hemostatic powder and pet-specific bandages. Key points: 1. Home kit - Lightweight and all-round for daily household inj...

What configurations do you recommend for different types of first aid kits? Recommended configurations: Home - band-aids, disinfecting wipes, gauze, tape, tourniquet, disposable gloves. Car - plus reflective vest, safety hammer, tow rope, emergency blanket. Industrial - plus hemostatic gauze, burn dressing, fixing splint, cleaning wipes. Outdoor - plus survival whistle, tourniquet, iodine swa...

What materials are commonly used for first aid kit cases? Common case materials: ABS is flame-resistant and drop-proof, PP is eco-friendly, aluminum alloy is durable and premium, and waterproof canvas is lightweight and flexible. Key points: 1. ABS - Flame-resistant, drop-proof and impact-resistant hard case. 2. PP - Eco-friendly recyclable plastic case. 3. Aluminum alloy - Premium dura...

Do you have sterilized (high-temperature / EO / irradiation) first aid kits? Yes. We provide EO (ethylene oxide) and irradiation sterilized medical-grade first aid kits, suitable for hospitals and clinics. Key points: 1. EO sterilized - Ethylene oxide sterilization for temperature-sensitive components. 2. Irradiation sterilized - Gamma/electron beam sterilization for mass production. 3....

What application scenarios are your first aid kits suitable for? Our first aid kits suit homes, offices, factories, construction sites, schools, outdoor activities, vehicles, boats and aircraft. Key points: 1. Home & office - Daily injury care for families and workplaces. 2. Factory & construction - Industrial kits with burn dressings and splints. 3. School & public - Compliance-oriente...

Which first aid kits are your bestsellers? The bestsellers are the 9-piece home kit, the car first aid kit, the industrial ABS box kit and the kids safety kit. Key points: 1. 9-piece home kit - Best-selling daily home care set with essential dressings and tools. 2. Car first aid kit - High-temperature resistant kit with traffic safety tools. 3. Industrial ABS box - Durable flame-resista...

What first aid kit products do you mainly offer? Our full range covers home kits, car kits, industrial kits, outdoor kits, kids safety kits, public place kits and sterilized medical kits. Key points: 1. Home kits - Lightweight all-round kits for daily household injuries. 2. Car & industrial - Vehicle kits with safety tools and industrial ABS box kits for workplaces. 3. Outdoor & kids - ...

Do you have DIN 13164 first aid kits? Why can't the contents be changed? DIN 13164 is the official German standard for vehicle first aid kits (Type B). The configuration is completely fixed and cannot be changed. The standard defines item types, quantities, specifications, sizes, packaging, expiry dates and labeling - any change makes the kit non-compliant. Key points: 1. Legally required -...

What are the core differences in first aid kit regulations between the US, EU, Germany and UK? EU: CE MDR with strict classification, technical file and EU Authorised Representative. US: FDA registration and labeling rules. Germany: DIN standard configurations such as DIN 13164. UK: UKCA, an independent certification after Brexit. Key points: 1. EU market - CE MDR, technical file plus EU Re...

Do pet first aid kits need medical device certification? In most countries pet first aid kits are regulated as pet products and do not require human medical device certification, but they must meet safety, non-toxic and RoHS/REACH requirements. Key points: 1. Pet product regulation - Most markets treat pet kits as general pet supplies, not medical devices. 2. Still safety-tested - Non-tox...

Which of your first aid kit models are medical devices and which are general goods? Models containing sterile medical supplies are medical devices (CE/FDA required). Models containing only tools such as scissors or non-sterile bandages are general goods. We clearly classify every model and provide the matching declaration plan. Key points: 1. Medical device models - Kits with sterile dressi...

What regulations apply when exporting first aid kits to our country? Depending on your market: EU CE MDR, US FDA, UK UKCA, Australia TGA, Germany DIN, and US OSHA for workplace kits. We adjust contents, provide registration documents, SDS and test reports, and handle compliant declaration throughout. Key points: 1. EU: CE MDR - Technical file plus EU Authorised Representative and EUDAMED re...

What do BSCI / Walmart factory audits check? BSCI and Walmart audits mainly review social compliance: working hours, wages, social insurance, fire safety, anti-discrimination, no child labor, environmental protection and production norms. Key points: 1. Labor practices - Working hours, wages, social insurance and contracts are checked against local law. 2. Safety & environment - Fire safe...

Which first aid products require medical device registration? Kits containing sterile medical supplies (sterile dressings, tourniquets, disinfectants) used for medical purposes are classified as medical devices in most countries and need CE/FDA/TGA registration. Kits containing only simple non-sterile tools can be declared as general goods. Key points: 1. Sterile supplies = device - Any ste...

What is the difference between MSDS and SDS? MSDS (Material Safety Data Sheet) is the old name, while SDS (Safety Data Sheet) is the current internationally unified name. The content is basically the same, mainly covering chemical composition, hazards and protective measures. Key points: 1. Same core content - Both documents state ingredients, hazard information, handling and first-aid meas...

What certifications are commonly required for first aid kits? (CE / ISO / FDA) Common certifications include ISO13485 (medical device quality system), CE MDR (EU), FDA (USA), UKCA (UK), TGA (Australia), plus SGS/BSCI factory audits. Together they cover all major global markets. Key points: 1. ISO 13485 - International quality management system for medical devices, recognized globally. 2. ...