4L Health Co., Ltd

Certificate CN23/00006256

Rev. 2Supplemented

Valid until: Nov 21, 2028

Certificate CN23/00006256 is a valid Quality management system issued to 4L Health Co., Ltd and registered in EUDAMED. Valid until November 21, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: CN23/00006256
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1639CN23/000062562

Validity

Issued: Jul 2, 2024
Valid from: Jul 2, 2024
Valid until: Nov 21, 2028

Manufacturer

Manufacturer: 4L Health Co., Ltd
Manufacturer SRN: CN-MF-000017929
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

Characteristics

Sterile: Yes
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: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

CN23/00006256Quality management systemIssuedNov 21, 2023 → Nov 21, 2028

Scope coverage

Class IIa4Class IIb2

6 scopes

MDA0308, MDS1009
Class IIa
MDN1204, MDS1005, EMDN: M040499
Class IIb
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIb

Documents

LanguagesEN