Tianjin Human-care Latex Corporation

Certificate HZ 2021286-1

Rev. 0Issued

Valid until: Jul 6, 2031

Certificate HZ 2021286-1 is a valid Quality management system issued to Tianjin Human-care Latex Corporation and registered in EUDAMED. Valid until July 6, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2021286-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2021286-10

Validity

Issued: Jul 7, 2026
Valid from: Jul 7, 2026
Valid until: Jul 6, 2031

Manufacturer

Manufacturer: Tianjin Human-care Latex Corporation
Manufacturer SRN: CN-MF-000026243
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

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 IIb1

1 scope

U110101 - MALE CONTRACEPTIVE DEVICES CONDOMS
Class IIb

Documents

LanguagesEN