Hangzhou Singclean Medical Products Co., Ltd.

Certificate V74 097027 0007

Rev. Rev. 01Supplemented

Valid until: Apr 1, 2029

Certificate V74 097027 0007 is a valid Technical documentation issued to Hangzhou Singclean Medical Products Co., Ltd. and registered in EUDAMED. Valid until April 1, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: V74 097027 0007
Certificate type: Technical documentation
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0123V74 097027 0007Rev. 01

Validity

Issued: Jan 20, 2025
Valid from: Jan 20, 2025
Valid until: Apr 1, 2029

Manufacturer

Manufacturer: Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer SRN: CN-MF-000014098
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

Covered devices

Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit (Colloidal Gold)IVDR Class B
69360201208J

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: No
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

Status changes

Supplemented

Supersedes

V74 097027 0007ReissuedApr 2, 2024 → Jan 19, 2025

Predecessor certificate not registered in EUDAMED.

Scope coverage

IVDR Class B1

1 scope

Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit (Colloidal Gold)
IVDR Class B
69360201208J

Documents

LanguagesEN