Shenzhen Krinwave Technology Co., Ltd.

Certificate FI25/1008014

Rev. Issue 2Supplemented

Valid until: Jun 2, 2030

Certificate FI25/1008014 is a valid Quality management system issued to Shenzhen Krinwave Technology Co., Ltd. and registered in EUDAMED. Valid until June 2, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: FI25/1008014
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0598FI25/1008014Issue 2

Validity

Issued: Jun 30, 2025
Valid from: Jun 30, 2025
Valid until: Jun 2, 2030

Manufacturer

Manufacturer: Shenzhen Krinwave Technology Co., Ltd.
Manufacturer SRN: CN-MF-000032042
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0598
Notified body country: Finland

Covered devices

Diagnostic Ultrasound SystemClass IIa
697532959A01100014P

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

Supplemented

Supersedes

FI25/1008014Quality management systemIssuedJun 3, 2025 → Jun 2, 2030

Scope coverage

Class IIa4

4 scopes

Diagnostic Ultrasound System
Class IIa
DEVICE
Class IIa
Diagnostic Ultrasound System, 697532959A012000152 Rocvue T9, T8, T7, T6, T5, T3 series
Class IIa
Diagnostic Ultrasound System, 697532959A021000154 Model:WE9, WE8, SE9, SE7 series
Class IIa

Documents

LanguagesEN