Kingstar Medical (Xianning) Co., LTD

Certificate G10 097364 0013

Rev. Rev. 03Supplemented

Valid until: Jan 29, 2028

Certificate G10 097364 0013 is a valid Quality management system issued to Kingstar Medical (Xianning) Co., LTD and registered in EUDAMED. Valid until January 29, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 097364 0013
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 097364 0013Rev. 03

Validity

Issued: Jun 11, 2026
Valid from: Jun 11, 2026
Valid until: Jan 29, 2028

Notified body

Notified body: TÜV SÜD Product Service GmbH
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: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

G10 097364 0013SupplementedJul 25, 2025 → Jan 29, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa17

17 scopes

M0201010201 - COTTON GAUZES, CUT, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201010202 - COTTON GAUZES, CUT, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
M0201020201 - COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201020202 - COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
M0201030201 - LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201030202 - LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
M0201050201 - COTTON GAUZE PADS, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201050202 - COTTON GAUZE PADS, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
M0202010201 - NON-WOVEN FOLDED GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0202010202 - NON-WOVEN FOLDED GAUZES, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
T0203 - DRESSING AND ASSISTANCE KITS
Class IIa
D0799 - ALCOHOLS FOR THE DISINFECTION OF MEDICAL DEVICES - OTHER
Class IIa
M0202010101 - NON-WOVEN FOLDED GAUZES, WITHOUT XRAY DETECTABLE THREAD, STERILE
Class IIa
M0202010102 - NON-WOVEN FOLDED GAUZES, WITHOUT XRAY DETECTABLE THREAD, NON-STERILE
Class IIa
M04040101 - SALINE DRESSINGS, NON-COMBINED
Class IIa
M0201020101 - COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201020102 - COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIa17

17 scopes

M0201010201 - COTTON GAUZES, CUT, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201010202 - COTTON GAUZES, CUT, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
M0201020201 - COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201020202 - COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
M0201030201 - LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201030202 - LAPAROTOMY COTTON GAUZES, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
M0201050201 - COTTON GAUZE PADS, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201050202 - COTTON GAUZE PADS, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
M0202010201 - NON-WOVEN FOLDED GAUZES, WITH X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0202010202 - NON-WOVEN FOLDED GAUZES, WITH X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa
T0203 - DRESSING AND ASSISTANCE KITS
Class IIa
D0799 - ALCOHOLS FOR THE DISINFECTION OF MEDICAL DEVICES - OTHER
Class IIa
M0202010101 - NON-WOVEN FOLDED GAUZES, WITHOUT XRAY DETECTABLE THREAD, STERILE
Class IIa
M0202010102 - NON-WOVEN FOLDED GAUZES, WITHOUT XRAY DETECTABLE THREAD, NON-STERILE
Class IIa
M04040101 - SALINE DRESSINGS, NON-COMBINED
Class IIa
M0201020101 - COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class IIa
M0201020102 - COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE
Class IIa

Certificate G10 097364 0013

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate G10 097364 0013

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer