Shenzhen Fitconn Technology Co.,ltd

Certificate FI26/1008022

Rev. Issue 1Issued

Valid until: Apr 16, 2031

Certificate FI26/1008022 is a valid Quality management system issued to Shenzhen Fitconn Technology Co.,ltd and registered in EUDAMED. Valid until April 16, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: FI26/1008022
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI26/1008022Issue 1

Validity

Issued: Apr 17, 2026
Valid from: Apr 17, 2026
Valid until: Apr 16, 2031

Manufacturer

Manufacturer: Shenzhen Fitconn Technology Co.,ltd
Manufacturer SRN: CN-MF-000024538
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0598
Notified body country: Finland

Covered devices

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa6

6 scopes

MDA 0313 EMDN code: V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES
Class IIa
MDA 0307 EMDN code: R060101 COLD NEBULISATION SYSTEMS
Class IIa
EMDN code: Z12040210 ULTRASONIC NEBULISERS
Class IIa
Anti Decubitus Mattress, Basic UDI-DI：69047048FUADMKH, models: FU-AM001, FU-AM002, FU-AM003, FU-AM001L
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

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