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ISO13485 Approved Full Face Silicone BIPAP CPAP
Reference: 1600359758595
Respiratory Equipments Accessories
Interested in this product?Ask about specifications, quantities and delivery.
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Product summary
Product Description
GoldHealth Medical presents a revolutionary sleep solution designed to redefine comfort and performance for users. Engineered with precision, this product is tailored for medical professionals, caregivers, and patients seeking an unparalleled experience in respiratory support.
Key Advantages
- Deft Design
- A brand-new forehead support frame offers a dynamic adjustment range, ensuring flexibility and lightweight comfort.
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The 360º rotating elbow allows unrestricted movement, enhancing user comfort during sleep.
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Unmatched Comfort
- Utilizes high-end double-layer liquid silicone technology for a soft, secure fit that prevents air leakage and ensures restful sleep.
- Self-adaptive pleated silicone cushion design flexibly adjusts to the user’s face, relieving pressure on the nasal bridge.
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A redesigned exhaust valve disperses airflow gently and quietly, minimizing disturbances for both users and their partners.
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Ease of Use
- Quick-detachable headgear buckles simplify wear and removal.
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Modular components allow effortless assembly, disassembly, and maintenance, ensuring hassle-free cleaning.
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Safety First
- Made from medical-grade, odorless silicone, ensuring safe and reliable use.
- Soft headgear materials are rigorously tested and approved for sensitive skin, offering peace of mind for all users.
Technical Specifications
- Frame: Lightweight, adjustable forehead support frame with a wide dynamic range.
- Cushion: Self-adaptive pleated silicone cushion with double-layer liquid silicone technology.
- Exhaust Valve: Advanced design for quiet and gentle airflow dispersion.
- Elbow: 360º rotation for maximum freedom of movement.
- Headgear: Quick-detachable buckles with soft, skin-friendly materials.
About GoldHealth Medical
GoldHealth Medical is a leader in the research, development, and distribution of advanced medical devices. Our team of experts includes software and hardware engineers, mechatronics specialists, and healthcare professionals dedicated to delivering innovative solutions.
Our commitment to quality is reflected in our certifications, including ISO9001, ISO13485, and CE. These standards ensure that our products meet the highest levels of safety and performance.
GoldHealth Medical products are trusted worldwide for their reliability, ease of use, and consistent quality. We take pride in serving hospitals, clinics, research institutions, and home users with cutting-edge technology designed to improve lives.
Why Choose GoldHealth Medical?
- Backed by a robust R&D team and a dedicated marketing and after-sales service team.
- Proven track record of delivering high-quality products at competitive prices.
- Global recognition for simple operation, steady performance, and customer satisfaction.
GoldHealth Medical is your trusted partner in advancing healthcare solutions.
Shipping & Delivery FAQ
How are products prepared before shipment?
Each item is checked against the catalog record, protected with suitable packaging materials, and prepared with available product documentation for procurement review.
Can you support international delivery requests?
The support team can coordinate delivery options by destination, product type, and documentation requirements before confirming availability.
Are fragile or calibrated products handled differently?
Sensitive products are packed with additional cushioning and handling notes; calibration or compliance documents can be reviewed during the inquiry process.
How can I estimate lead time?
Lead time depends on stock status, destination, carrier availability, and any requested documentation. Contact the product team for a product-specific estimate.
Before you choose a medical product
Practical answers about product configuration, consumables, documents, quantities and support before a medical supply inquiry.
How do I confirm the right model and configuration?
Include the product reference, intended care setting and the functions or dimensions you need. Ask which accessories are included and which are optional. Images and a shared product name may cover more than one configuration, so confirm the exact version in the supplier response.
Will accessories or consumables fit my existing equipment?
Provide the equipment manufacturer, model and the relevant connector, size or part reference. Request compatibility information for the specific combination rather than relying on visual similarity. Follow the equipment and accessory manufacturers' instructions.
Which product documents can I request?
Depending on the product, useful requests may include a specification sheet, instructions for use, packaging details or available regulatory documents. State your destination market and the exact document required. A catalog listing does not establish that every model has a particular approval or certification.
Are all consumables sterile or suitable for single use?
No assumption should be made across the catalog. Check the labeling and instructions for the exact product, including whether it is supplied sterile, its stated use, expiry information and storage requirements. Ask for clarification before purchasing if these details are missing.
Can I ask about samples, pack sizes or minimum quantities?
Yes. Tell us the item reference, the quantity you want to evaluate and the quantity expected for the project. Sample availability, pack sizes and minimum purchase quantities depend on the product and must be confirmed individually.
What should I confirm for installation and ongoing use?
For equipment, ask about power supply, installation space, setup instructions, training materials, spare parts and the applicable service or warranty terms. Confirm which support is available for the selected model and destination before agreeing to a purchase.
How are price, lead time and delivery confirmed?
Send quantities, destination and required timing with your inquiry. Request a written response covering the selected configuration, packing, commercial terms and delivery estimate. Published product information is a starting point; an inquiry is not an order confirmation.
About Gold Health
Medical supplies for the way care is delivered
Explore Gold Health: medical equipment, clinical consumables and veterinary supplies for professional procurement.
Different care settings, one place to begin
A hospital department, an independent clinic, a laboratory and a veterinary practice can have very different purchasing needs. Our catalog brings equipment, instruments and everyday supplies into a browsable starting point for these different settings.
Explore by category, inspect the product images and use the listed details to build a shortlist. Availability and the exact configuration are confirmed for the selected item when you contact the team.
Look beyond the product name
A useful product choice depends on more than a headline. Dimensions, materials, model references, accessories, packaging and instructions can all affect whether an item belongs on your purchasing list.
We encourage buyers to identify these details early and ask for the product-specific information they need before making a decision.
Equipment and consumables need different questions
For equipment, ask about the supplied configuration, compatible accessories, electrical requirements and available service information. For consumables, confirm the stated intended use, pack quantity, storage conditions and any sterile or single-use labeling for that exact item.
The catalog helps organize the conversation. Product suitability and any clinical use must be assessed using the relevant manufacturer instructions and qualified professional review.
Turn a shortlist into a useful conversation
Send the product names or references together with your quantities, destination and preferred timing. If several items form one project, explain which accessories or consumables need to work together.
This gives the team a practical basis for discussing specifications, available documents, packaging and the next commercial steps. Please keep patient information and other sensitive records out of your inquiry.
Product attributes
Product Overview
GoldHealth Medical presents the EaseFit FMII, a meticulously engineered medical solution designed to deliver precision, comfort, and reliability. Crafted with advanced materials and adhering to the highest industry standards, this Class II medical instrument is ideal for hospitals, clinics, research institutions, and home care environments.
Key Features and Benefits
- Superior Material Composition: Constructed from high-grade plastic and medical-grade silicone, ensuring durability, hygiene, and user comfort.
- Manual Power Source: Designed for simplicity and reliability, eliminating dependency on external power sources.
- Compact and Portable Design: Lightweight at just 1.000 kg with dimensions of 100x20x20 cm, making it easy to store, transport, and deploy in any setting.
- 6-Month Shelf Life: Ensures product integrity and performance when stored under recommended conditions.
Certifications and Compliance
- Class II Instrument Classification: Meets rigorous safety and performance standards for medical devices.
- CE Certification: Validated for quality, safety, and compliance with European health and safety regulations.
Support and Service
- Comprehensive After-Sales Support: Backed by GoldHealth Medical’s commitment to customer satisfaction.
- Online Technical Support: Access expert guidance and troubleshooting assistance whenever you need it.
Packaging Details
- Selling Units: Single item
- Package Dimensions: 100x20x20 cm
- Gross Weight: 1.000 kg
GoldHealth Medical’s EaseFit FMII is more than a product—it’s a reliable partner in delivering exceptional care. Designed with precision and built to last, it’s the ideal choice for professionals and caregivers seeking uncompromising quality.
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