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Shenzhen Fitconn Technology Co.,ltd

China Last updated 8 Jun 2026

Devices
37
Registries
EUDAMEDFDA
FDA recalls
0

Catalogue37

EUDAMED certificates1

EUDAMED certificates (1)

SGS FIMKO OY 0598 1 certificate

  • FI26/1008022 Supplemented

    Quality management system EU MDR

    Issued
    1 Jul 2026
    Expires
    16 Apr 2031
    Reason
    Other

Related companies

Authorised representatives

Notified bodies

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Shenzhen Fitconn Technology Co., Ltd. US

About

Shenzhen Fitconn Technology Co.,ltd was founded in 2012 (its predecessor, Fure Industry Co.,Ltd., was established in Hong Kong in 2007). It is a comprehensive enterprise dedicated to the research and development, manufacturing, sales and after-sales service of household medical products.

From the manufacturer's own website. Source

What Shenzhen Fitconn Technology Co.,ltd makes

The company manufactures compressor and mesh nebulizers, which are devices used to deliver medication in aerosol form for respiratory treatments. It also produces two branded inhaler systems, FEELO and SilMed, designed for controlled drug administration. These products are primarily intended for home use and chronic respiratory management.

The portfolio includes Class IIa medical devices, which are regulated under EU medical device directives and listed in the EUDAQS database (eudamed). The company is based in Shenzhen, China, and its products comply with relevant regulatory standards for respiratory therapy devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does Shenzhen Fitconn Technology Co.,ltd have in the registry?

The registry currently lists 37 devices for Shenzhen Fitconn Technology Co.,ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Shenzhen Fitconn Technology Co.,ltd's devices?

Among its 37 most recently registered devices, Shenzhen Fitconn Technology Co.,ltd has devices listed in EUDAMED (37 devices).

What risk classes do Shenzhen Fitconn Technology Co.,ltd's devices fall under?

Among its 37 most recently registered devices, the classes recorded for Shenzhen Fitconn Technology Co.,ltd's devices are Class IIa. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Shenzhen Fitconn Technology Co.,ltd?

EUDAMED lists 1 certificate for Shenzhen Fitconn Technology Co.,ltd (quality management system) under MDR. The most recent was issued on 2026-07-01.

What are the newest devices from Shenzhen Fitconn Technology Co.,ltd in the registry?

The most recently registered devices listed for Shenzhen Fitconn Technology Co.,ltd include Ultra-Quiet Portable Nebulizers, Compressor Nebulizer, Mesh Nebulizer and FEELO.

Which FDA establishments are linked to Shenzhen Fitconn Technology Co.,ltd?

1 FDA establishment is linked to Shenzhen Fitconn Technology Co.,ltd in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

Information

Address
NO.116, Songgang street, Shenzhen, China
Phone
+86-755-83758230
PRRC contact
Xianze Yu
EUDAMED SRN
CN-MF-000024538