Shenzhen Yimi Life Technology Co., Ltd

Certificate FI26/1008021

Rev. Issue 1Issued

Valid until: Apr 1, 2031

Certificate FI26/1008021 is a valid Quality management system issued to Shenzhen Yimi Life Technology Co., Ltd and registered in EUDAMED. Valid until April 1, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: FI26/1008021
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI26/1008021Issue 1

Validity

Issued: Apr 2, 2026
Valid from: Apr 2, 2026
Valid until: Apr 1, 2031

Manufacturer

Manufacturer: Shenzhen Yimi Life Technology Co., Ltd
Manufacturer SRN: CN-MF-000029928
Manufacturer country: China

Notified body

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

Covered devices

No specific devices are listed for this certificate.

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 IIa5

5 scopes

MDA 0203, MDT 2010, MDT 2011 EMDN Z1203020408 Pulse Oximeters
Class IIa
MDA 0203, MDT 2010, MDT 2011 EMDN Z1203020501 Non-Invasive Oscillometric Blood Pressure Gauges
Class IIa
Fingertip Pulse Oximeter, Basic UDI-DI: 697291137YM4A, Model: YM101, YM102, YM103, YM104, YM201, YM202, YM301, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM401, YM402, YM403, YM501, YM502, YM503, YM504, YM601, YM602, YM603
Class IIa
Pulse Oximeter, Basic UDI-DI: 697291137YH3Y, Model: YH01, YH02
Class IIa
Upper Arm Electronic Blood Pressure Monitor, Basic UDI-DI: 697291137YP4G, Model: YP7101, YP7201, YP7202
Class IIa

Documents

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