AOJ HEALTH Technology Co., Ltd.

Certificate FI24/1008006

Rev. Issue 5Supplemented

Valid until: Mar 17, 2028

Certificate FI24/1008006 is a valid Quality management system issued to AOJ HEALTH Technology Co., Ltd. and registered in EUDAMED. Valid until March 17, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: FI24/1008006
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0598FI24/1008006Issue 5

Validity

Issued: Apr 7, 2026
Valid from: Apr 8, 2026
Valid until: Mar 17, 2028

Manufacturer

Manufacturer
Manufacturer SRN: CN-MF-000037449
Manufacturer country: China

Notified body

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

Covered devices

Insect Bite HealerClass IIa
697631375IBXTG

Characteristics

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

History

Status changes

Supplemented

Supersedes

FI24/1008006Quality management systemReissuedMar 12, 2026 → Mar 17, 2028

Scope coverage

Class IIa6

6 scopes

MDA 0305, MDT 2010, MDT 2011 V9099 - Various devices not included in other classes - other
Class IIa
MDA 0306, MDT 2010, MDT 2011 EMDN code: Z12080303 Breast Pumps
Class IIa
MDA 0307, MDT 2010, MDT 2011 EMDN code: R060101 Cold Nebulisation System
Class IIa
DEVICE
Class IIa
Electric Breast Pump; Model: BRP-301, BRP-302, BRP-303, BRP-304, BRP-305, BRP-306, BRP-307, BRP-308, BRP201, BRP-202, BRP-203 Basic UDI-DI: 697631375BRPXQJ
Class IIa
Compressor Nebulizer; Model: NEB-CP01, NEB-CP03, NEB-CP04, NEB-MP01, NEB-MP02, NEB-MP03 Basic UDI-DI: 697631375NEBXPT
Class IIa

Documents

LanguagesEN