What certifications does the product have?

The product is certified with CE and ISO13485.

Home Use Hospital Medical CE Certified Portable Inhaler Compressor Nebulizer Machine

Name: Home Use Hospital Medical CE Certified Portable Inhaler Compressor Nebulizer Machine
Brand: Shenzhen Fitconn Technology Co., Ltd.
SKU: 1975879615

Guangdong, ChinaShenzhen Fitconn Technology Co., Ltd.

US$13.00

8-999 Pieces

US$9.50

1,000-1,999 Pieces

US$9.60

2,000+ Pieces

Sample price:US$13.00/piece.Request sample

Product profile

Customization

Available

Type

Dental

Function

Other

Model NO.

CNB69025

Theory

Electrotherapeutics

Certification

CE, ISO13485

LCD Display

Without LCD Display

Group

Adult

Transport Package

Color Box

Specification

ISO CE

Trademark

Fitconn

Origin

Guangdong, China

HS Code

9019200000

Production Capacity

10000 Set/Sets Per Month

Key features

CE and ISO13485 Certified: Meets international safety and quality standards for medical devices.

Oil-Free High-Efficiency Valve: Eliminates need for daily lubrication and ensures reliable operation.

OEM Logo and Packaging Service: Customize product with your logo or specific packaging design available.

High Flow Performance: Liter flow range exceeds 6.7lpm for efficient medication delivery.

Compact Portable Design: Dimensions 270*115*240mm make it easy to transport and store.

Fast Off-Season Delivery: Average lead time within 15 workdays during off-peak seasons.

Company profile

Years of Export ExperiencePatents AwardedQuality AssuranceManagement Certification

Shenzhen Fitconn Technology Co., Ltd.

Guangdong, China

Business Type: Manufacturer/Factory, Trading CompanyExport Year: 2007-03-01Nearest Port: ShzhenAverage Response Time: ≤8.21hTerms of Payment: LC, T/T, PayPal, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, FCA

AI-Powered supplier vetting

SummaryShenzhen Fitconn Technology Co., Ltd. is a medical-products manufacturer established in 2012, with a 4,988-square-meter factory and seven production lines. It holds Class II medical device production qualification, ISO 13485 and RoHS certifications, while some products reportedly have EU CE and FDA certification. The supplier demonstrates broad customization, ODM, OEM for well-known brands, SDK availability, raw-material traceability, and 100% finished-product inspection. Its stated nebulizer output is 1,200,000 sets annually, with seven quality inspectors reported in one record and six to ten quality-control staff in another. The company has valid contracts with associated subcontractors and documented supplier-assessment procedures. It lacks in-stock capacity, overseas warehouses, overseas showrooms, and overseas agents or branches, but offers services in Poland and has participated in MEDICA 2024. Financial credibility cannot be assessed because the provided financial entries identify years only and...

Supplier typeThe supplier is described as a comprehensive household medical-products enterprise covering research and development, manufacturing, sales, and after-sales service. Its records also identify nebulizers and sets as annual productivity information, supporting classification as a medical-device manufacturer.

CertificationsThe company states that it holds Class II medical device production qualification, ISO 13485 quality-system certification, and RoHS certification; some products have also passed EU CE and FDA certification. These are explicit credentials relevant to medical-product manufacturing, although the scope of the CE and FDA coverage is not specified.

After-Sales capabilityThe company description explicitly includes after-sales service, and the supplier reports service coverage in Poland. However, it has no overseas agents or branches, overseas warehouse, or overseas showroom, so the available evidence supports basic after-sales capability but not extensive overseas infrastructure.

R&D capabilityThe supplier reports R&D operations, new products within the past year, more than 25 patents, ODM capability, SDK availability, and six to ten years of total R&D-engineer experience. These explicit indicators demonstrate established innovation resources and activity.

Production capacityThe supplier reports seven production lines, annual nebulizer output of 1,200,000 sets, 100% finished-product inspection, raw-material traceability, and valid contracts with associated subcontractors. It also states peak- and off-season lead times within 15 workdays, while lacking in-stock capacity.

Customization capabilityThe supplier explicitly offers customization from samples, designs, full customization, minor customization, and flexible customization, together with ODM services. The same broad customization list appears in two records, providing strong direct evidence of customization capability.

Client casesThe supplier states that it provides OEM services for well-known brands and participates in major domestic and international medical exhibitions, including MEDICA 2024. These records indicate brand-related and market-facing experience, but do not identify specific customer names or detailed project cases.