What certifications does the nebulizer have?

The product is certified with CE, ISO13485, and Fcs.

Home Health Care Handheld Mini DC Compressor Nebulizer Machine with Adapter

Name: Home Health Care Handheld Mini DC Compressor Nebulizer Machine with Adapter
Brand: Shenzhen Fitconn Technology Co., Ltd.
SKU: 1988940305

Guangdong, ChinaShenzhen Fitconn Technology Co., Ltd.

US$14.00

6-59 Pieces

US$12.50

60-179 Pieces

US$11.90

180-599 Pieces

US$11.50

600-999 Pieces

US$10.80

1,000+ Pieces

Sample price:US$13.00/piece.Request sample

Product profile

Customization

Available

Type

Compressor Nebulizer

Function

Aerosol Therapy of Asthma,Allergies Ect.

Model NO.

CDC-200

Theory

Ultrasonic

Certification

CE, ISO13485, Fcs

LCD Display

Without LCD Display

Group

Adult and Children

Product Size

59X59X131mm

Transport Package

Color Box

Specification

Particle size: 0.5-10um

Trademark

Fitconn

Origin

China

HS Code

9019200000

Production Capacity

1000000

Key features

OEM Service Available: Custom logo printing and packaging design services provided for bulk orders.

Oil-Free Valve System: Adopts oil-free-high-efficiency valve requiring no daily lubrication.

Certified Quality: CE, ISO13485, and Fcs certified for safety and reliability.

Minimal Residual Drug: Residual amount <0.8mL ensures efficient medication delivery.

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: ≤7.82hTerms 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.