What materials are used for the resuscitator?

Our resuscitators are available in PVC, silicone, and SEBS materials, with silicone being reusable and reducing infection risk.

What certifications does the product have?

The product holds CE, FDA, and SGS certifications, and our factory is ISO 13485 certified.

Silicone Reusable CE FDA Ambu Bag Manual Resuscitation Kit

Name: Silicone Reusable CE FDA Ambu Bag Manual Resuscitation Kit
Brand: Ningbo Hanyue Medical Technology Co.,Ltd
SKU: 2225162325

Zhejiang, ChinaNingbo Hanyue Medical Technology Co.,Ltd

US$9.00-11.00

200 Pieces

Sample price:US$12.00/piece.Request sample

Product profile

Customization

Available

Type

Face Mask/Apron/Gloves

Material

Silicone

Model NO.

HY-004

Quality Guarantee Period

3 Years

Group

Infant/Pedia/Adult

Single Gross Weight

0.760 Kg

Instrument Classification

Class II

Disinfecting Type

Far Infrared

Safety Standard

None

Quality Certification

SGS

Transport Package

Carton

Specification

Adult/Pediatric/Infant/Neonate

Trademark

Hanyue

Origin

Zhejiang, China

HS Code

9020000000

Key features

Reusable Silicone Material: Made of high-quality silicone to reduce cross-infection risk and ensure long-term reuse.

4-in-1 Intake Valve: Features a new 4-in-1 intake valve design for simple structure and convenient operation.

Multiple Size Options: Available in Infant, Pediatric, Adult, and Neonate sizes to suit different patient groups.

CE & FDA Certified: Product meets CE and FDA standards for safety and quality assurance.

OEM & ODM Service: Supports custom manufacturing including samples, designs, and full customization options.

3-Year Warranty: Comes with a 3-year quality guarantee period for peace of mind.

ISO 13485 Certified: Factory holds ISO 13485 certification ensuring strict quality control processes.

Fast Sample Delivery: Sample orders are prepared and ready within 3 days for quick evaluation.

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.