Suzhou Frankenman Medical Equipment Co.,Ltd

Certificate G15 091657 0022

Rev. Rev. 01Supplemented

Valid until: Mar 20, 2030

Certificate G15 091657 0022 is a valid Quality management system issued to Suzhou Frankenman Medical Equipment Co.,Ltd and registered in EUDAMED. Valid until March 20, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: G15 091657 0022
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G15 091657 0022Rev. 01

Validity

Issued: Jun 9, 2026
Valid from: Jun 9, 2026
Valid until: Mar 20, 2030

Manufacturer

Manufacturer: Suzhou Frankenman Medical Equipment Co.,Ltd
Manufacturer SRN: CN-MF-000012943
Manufacturer country: China

Notified body

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

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

Status changes

Supplemented

Supersedes

G15 091657 0022SupplementedMar 21, 2025 → Jun 8, 2026

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class I2

2 scopes

H020280 - STAPLERS FOR OPEN SURGERY - ACCESSORIES
Class I
H020301 - LINEAR STAPLERS FOR VIDEOSURGERY
Class I

Documents

LanguagesEN