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Shenzhen Fitfaith Technology Co., Ltd

Active in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000019124

Devices
16
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
Authorised rep.
Lotus NL B.V.NL

What Shenzhen Fitfaith Technology Co., Ltd makes

Shenzhen Fitfaith Technology Co., Ltd manufactures finger pulse oximeters, including models such as the F380 and generic pulse oximeters designed for non-invasive blood oxygen saturation monitoring. These devices measure oxygen levels in the blood and heart rate via a sensor placed on the fingertip, primarily for clinical and home use.

The company’s products fall under EU Class IIa medical devices and are registered in the EU’s eudamed database. The manufacturer is based in China and adheres to relevant regulatory requirements for these categories.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

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  • Fitfaith M160

    Withdrawn Registry: GUDID Class:II
  • Fitfaith M130

    Withdrawn Registry: GUDID Class:II
  • Fitfaith M230

    Withdrawn Registry: GUDID Class:II
  • Fitfaith M230E

    Withdrawn Registry: GUDID Class:II
  • Fitfaith M130E

    Withdrawn Registry: GUDID Class:II
  • Fitfaith M110E

    Withdrawn Registry: GUDID Class:II
  • Fitfaith M170

    Withdrawn Registry: GUDID Class:II
  • Fitfaith M160E

    Withdrawn Registry: GUDID Class:II
  • Fitfaith M170E

    Withdrawn Registry: GUDID Class:II
  • Fitfaith M110

    Withdrawn Registry: GUDID Class:II
  • F380

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa
  • Finger Pulse Oximeter Ref 130

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa
  • Finger Pulse Oximeter Ref 160

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa
  • Finger Oximeter Ref 380

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • Pulse Oximeter Ref 100

    Active Regimes: CE MDD Registry: EUDAMED Class:IIa
  • Finger Pulse Oximeter Ref 170

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

Rows 1-16 of 16

Company details

EUDAMED SRN
CN-MF-000019124
DUNS number
544436982
EUDAMED status
Active
EUDAMED registered name
Shenzhen Fitfaith Technology Co., Ltd.
Registered address
501, Building B5, Dongfang Jianfu Yijing Industrial City,Tianliao Community, Yutang Street, Guangming District, Shenzhen,P.R. China, 518132, Shenzhen, China
PRRC contact
Junfeng Yuan(public in EUDAMED)

Frequently asked questions

How many devices does Shenzhen Fitfaith Technology Co., Ltd have in the registry?

The registry currently lists 16 devices for Shenzhen Fitfaith Technology Co., Ltd. Devices recorded under merged duplicate company entries are counted once.

Which registries list Shenzhen Fitfaith Technology Co., Ltd's devices?

Among its 16 most recently registered devices, Shenzhen Fitfaith Technology Co., Ltd has devices listed in EUDAMED (6 devices) and FDA GUDID (10 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Shenzhen Fitfaith Technology Co., Ltd's devices fall under?

Among its 16 most recently registered devices, the classes recorded for Shenzhen Fitfaith Technology Co., Ltd's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Shenzhen Fitfaith Technology Co., Ltd in the registry?

The most recently registered devices listed for Shenzhen Fitfaith Technology Co., Ltd include Fitfaith M160, Fitfaith M130, Fitfaith M230 and Fitfaith M230E.

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