FDA Approved Moderate Price Silicone Reusable Full Face CPAP Mask Bipap Mask

Name: FDA Approved Moderate Price Silicone Reusable Full Face CPAP Mask Bipap Mask
Brand: Ningbo Hanyue Medical Technology Co.,Ltd
SKU: 2232975545

Zhejiang, ChinaNingbo Hanyue Medical Technology Co.,Ltd

US$14.00-17.00

20 Pieces

Sample price:US$30.00/piece.Request sample

Product profile

Customization

Available

Type

Face Mask/Apron/Gloves

Material

Silicone

Model NO.

HY-008

Quality Guarantee Period

3 Years

Group

Adult

Instrument Classification

Class II

Disinfecting Type

Far Infrared

OEM

Available

Color

Transparent

Transport Package

Carton

Specification

Normal

Trademark

Hanyue

Origin

Zhejiang, China

Key features

FDA Approved: Product meets FDA standards for Class II medical devices.

Soft Silicone Cushion: Provides comfort wearing and good sealing for full face mask.

Wide Vision Design: Full face mask design offers wide vision for user comfort.

Universal Compatibility: Compatible with most breathing machines including CPAP and BiPAP.

3 Years Shelf Life: Guaranteed shelf life of 3 years for the silicone mask.

OEM and ODM Available: Customization services including OEM and ODM are available.

ISO 13485 Certified: Factory certified with ISO 13485 and FDA approval.

Transparent Color: Product features a transparent color option.

Company profile

Importers and ExportersHigh Repeat Buyers ChoiceSelf-branded

Ningbo Hanyue Medical Technology Co.,Ltd

Zhejiang, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 3 Years CertifiedNearest Port: Ningbo Port, Shanghai PortAverage Response Time: ≤1.56h

AI-Powered supplier vetting

SummaryNingbo Hanyue Medical Technology Co., Ltd. operates across medical research, Class I medical devices, rubber and plastic products, and related technical services. It has three production lines, 12 years of combined R&D engineer experience, inventory capability, 100% finished-product inspection, and documented corrective-action and customer-complaint procedures. The supplier provides OEM/ODM-related customization and 3D design services, but reported no new products in the past year. Its manufacturing capacity lacks a valid contract with affiliated subcontractors, and it has no overseas warehouses, agents, branches, showrooms, or offline trade-show participation. Quality assurance is stated as available, while supplier approval records lack signatures or dates. Digital management capability is limited, with no ERP integration and zero reported OA, CRM, or SAP capability. The evidence is insufficient to establish customer cases or formal certification holdings.

Supplier typeThe supplier is identified as a combined company whose scope includes medical research and technical services, Class I medical device production, rubber and plastic manufacturing, and sanitary products. It operates three production lines, indicating an integrated manufacturing and service-oriented profile rather than a purely trading business.

After-Sales capabilityThe supplier has clear procedures and followed records for corrective and preventive actions and customer complaints, supporting internal service-response capability. However, it has no overseas agents or branches, no overseas warehouse, no overseas showroom, and reports service coverage in zero countries, limiting demonstrated international after-sales reach.

R&D capabilityThe supplier has 12 years of total R&D engineer experience, offers 3D software design and ODM services, and supports several customization modes. However, it reported no new products during the past year and has no available SDK, so the evidence supports design and development capacity but not strong recent product innovation.

Production capacityProduction capability is supported by three production lines, injection and blow molding equipment, Class I medical device and rubber/plastic manufacturing scope, inventory capability, and 100% finished-product inspection with standardized instructions. A material operational weakness is that the factory and affiliated subcontractors have no valid manufacturing-capacity contract; production digitalization is also limited because ERP, OA, CRM, and SAP capabilities are absent or reported as zero.

Customization capabilityThe supplier explicitly offers 3D software design services and customization from samples, designs, full requirements, minor requirements, and flexible requirements. These capabilities are reported consistently in both R&D and design-service records, indicating broad customization support.

Product Q&A

Q:Can I get some samples?

We are honored to send you our samples, but the express fee need to paid by your company .

Q:How about the delivery time?

1).For Samply order will be prepared within 3 days. 2)For bulk order, normally, it needs 10-25 days, it's based on you QTY.

Q:Can you do custom-made?

OEM, ODM are available.

Q:How about the shipping?

1)For sample order, it can sent by express company like UPS,Fedex,TNT ect.We have strong cooperation with them and if you have express collected account,you will no need to pay us. 2)For bulk order, it can be shipping by sea.

Q:How about your service?

1).Any Inquiries will be replied within 24 hours. 2)Professional company, qualityissue, competitive price. 3).All products will be strictly quality checked and well-packed before shipping.