2026 New Digital Mdr Certified Handheld Nebulizer with Easy Replace Mesh Plate

Name: 2026 New Digital Mdr Certified Handheld Nebulizer with Easy Replace Mesh Plate
Brand: Shenzhen Fitconn Technology Co., Ltd.
SKU: 2305172075

Guangdong, ChinaShenzhen Fitconn Technology Co., Ltd.

US$9.50

500-999 Pieces

US$9.40

1,000-4,999 Pieces

US$9.00

5,000+ Pieces

Sample price:US$12.00/piece.Request sample

Product profile

Customization

Available

Cold Hot Dressing Application

Home Use

Usage Mode

Home Use

Model NO.

MY-151B

Nature

Yes

Customized

Type

Medical

Group

All

Certification

CE, FDA, EEC, MSDS, ISO13485

Application

for Commercial & Home Use

Safety Standard

GB/T18830-2009

Power Supply Mode

Lithium Battery:3.7V, 1200mAh

Instrument Classification

Class II

Nebulization Rate

>0.25ml/Min

Working Voice

≤50db(a)

Particle Size

Mdma<5μm

Transport Package

1 PC/ Color Box, 45PCS/Carton

Specification

Carton Size: 44*41*45cm G.W./N.W.: 14.56/15.56kg

Trademark

Fitconn

Origin

China

HS Code

9019200000

Production Capacity

1000000

Key features

LED Display Nebulizer

Self-Cleaning Nebulizer

Replaceable Mesh Cup / Replaceable Mesh Plate

Dual Mode Nebulizer (Adult / Child)

Manual Atomization Control

IP22 degree

Quiet Operation Nebulizer

MDR CE, ISO13485, MDL, SFDA, MDSAP, MHRA certification,

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.

Product Q&A

Q:What is a mesh nebulizer and how does it work?

A mesh nebulizer uses a vibrating mesh membrane with microscopic holes to convert liquid medication into a fine aerosol mist. The mesh vibrates a

Q:What respiratory conditions can this nebulizer treat?

This nebulizer is designed to relieve symptoms associated with: Asthma, Cold and Flu, Cough, Bronchitis, Pharyngitis, Upper respiratory tract infections Other respiratory conditions requiring inhaled medication Please note: This device is an atomization delivery tool. Always use prescribed medication as directed by your physician.

Q:How should I clean and maintain the Mesh Nebulizer?

After each use, rinse the medication cup and mesh part according to the user manual to prevent residue buildup. Proper cleaning and regular maintenance help maintain stable nebulization performance and extend the service life of the device

Q:What certifications does Fitconn Mesh Nebulizer have?

MDR CE,FDA,ISO13485,Free Sales Certificate, Declaration of Conformity, EU-REP,MDSAP, SFDA, MDL MDMA, MHRA(UK), NMPA, ANVISA, INMETRO

Q:What is the particle size?

The device generates particles with a median diameter of 3.5um, This particle size is optimal for deep lung deposition, allowing the medication to reach the alveoli where absorption is most effective