Takaso Rubber Products Sdn Bhd

Certificate MY24/00000024

Rev. 2Amended

Valid until: Jan 15, 2029

Certificate MY24/00000024 is a valid Quality management system issued to Takaso Rubber Products Sdn Bhd and registered in EUDAMED. Valid until January 15, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: MY24/00000024
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1639MY24/000000242

Validity

Issued: Feb 8, 2024
Valid from: Feb 8, 2024
Valid until: Jan 15, 2029

Manufacturer

Manufacturer: Takaso Rubber Products Sdn Bhd
Manufacturer SRN: MY-MF-000028366
Manufacturer country: Malaysia

Notified body

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

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

MY24/00000024Quality management systemIssuedJan 15, 2024 → Jan 15, 2029

Scope coverage

Class IIb2

2 scopes

MDN1210, EMDN:U110101
Class IIb
Smooth and Textured Non-Sterile Non-Medicated Natural Rubber Latex Condom
Class IIb

Documents

LanguagesEN