MDR MDR QMS Supplemented

CN23/00006256

Manufacturer: 4L Health Co., Ltd
Basic UDI-DIs
0
Scopes
6
Preceding Certs
1
Risk Classes
2
Characteristics
0
Revision
2
897
Valid for 897 days
Expiry: November 21, 2028

Basic Information

Number
CN23/00006256
Type
MDR QMS
Legislation
MDR
Issue Date
July 2, 2024
Expiry Date
November 21, 2028
Revision
2
Manufacturer
4L Health Co., Ltd

Certificate Lifecycle

July 2, 2024 November 21, 2028

Device Characteristics

Sterile

Scopes

6 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIa

MDA0308, MDS1009

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Group Class IIb

MDN1204, MDS1005, EMDN: M040499

Quality Procedure Scope

Device Class IIb

Preceding Certificates

CN23/00006256 Issued
Issued: November 21, 2023 Expires: November 21, 2028

Basic UDI-DIs

This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.