Guangzhou Double One Latex Products Co., Ltd.

Certificate C558623

Rev. 0Issued

Valid until: May 10, 2031

Certificate C558623 is a valid Quality management system issued to Guangzhou Double One Latex Products Co., Ltd. and registered in EUDAMED. Valid until May 10, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: C558623
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2460C5586230

Validity

Issued: May 11, 2026
Valid from: May 11, 2026
Valid until: May 10, 2031

Manufacturer

Manufacturer: Guangzhou Double One Latex Products Co., Ltd.
Manufacturer SRN: CN-MF-000023131
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 2460
Notified body country: Norway

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: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Natural Rubber Latex Male Condoms: Used for contraception and preventing from STIs.
Class IIb
Natural Rubber Latex Male Condom Models: W49mm Smooth no color no flavour condom W53mm Smooth no color no flavour condom W55mm Smooth no color no flavour condom W53mm Smooth no color strawberry flavour condom W53mm Smooth red color strawberry flavour condom
Class IIb

Documents

LanguagesEN