Kingstar Medical (Xianning) Co., LTD

Certificate G11 097364 0014

Rev. Rev. 03Supplemented

Valid until: Jan 29, 2028

Certificate G11 097364 0014 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: G11 097364 0014
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G11 097364 0014Rev. 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: No
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

G11 097364 0014SupplementedJul 25, 2025 → Jan 29, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class I21

21 scopes

M010102 - PURE COTTON
Class I
M0201010101 - COTTON GAUZE, CUT, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class I
M0201020101 - COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class I
M0201030101 - LAPAROTOMY COTTON GAUZES, WITHOUT XRAY DETECTABLE THREAD, STERILE
Class I
M0201050101 - COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class I
M0202010101 - NON-WOVEN FOLDED GAUZES, WITHOUT XRAY DETECTABLE THREAD, STERILE
Class I
M0202030101 - NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class I
M020204 - NON-WOVEN GAUZES IN PIECES
Class I
M03030101 - ELASTIC FIXING BANDAGES, NON-ADHESIVE
Class I
M03040101 - ELASTIC COMPRESSION BANDAGES, NONADHESIVE
Class I
M03040202 - ELASTIC SUPPORT BANDAGES, COHESIVE (SELF-ADHESIVE)
Class I
M0401 - PREPARED DRESSINGS
Class I
M04010101 - NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD
Class I
M040204 - NON-ADHERENT ABSORBENT DRESSINGS
Class I
M040299 - NON-ADHESIVE ABSORBENT DRESSINGS - OTHER
Class I
M040301 - EYE PADS, COTTON OR NON-WOVEN MATERIALS
Class I
T0201 - SURGICAL DRAPES
Class I
T020401 - STANDARD SURGICAL GOWNS
Class I
T0205 - NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Class I
T020699 - MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER
Class I

1 / 2

Documents

LanguagesEN

Scope coverage

Class I21

21 scopes

M010102 - PURE COTTON
Class I
M0201010101 - COTTON GAUZE, CUT, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class I
M0201020101 - COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class I
M0201030101 - LAPAROTOMY COTTON GAUZES, WITHOUT XRAY DETECTABLE THREAD, STERILE
Class I
M0201050101 - COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class I
M0202010101 - NON-WOVEN FOLDED GAUZES, WITHOUT XRAY DETECTABLE THREAD, STERILE
Class I
M0202030101 - NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE
Class I
M020204 - NON-WOVEN GAUZES IN PIECES
Class I
M03030101 - ELASTIC FIXING BANDAGES, NON-ADHESIVE
Class I
M03040101 - ELASTIC COMPRESSION BANDAGES, NONADHESIVE
Class I
M03040202 - ELASTIC SUPPORT BANDAGES, COHESIVE (SELF-ADHESIVE)
Class I
M0401 - PREPARED DRESSINGS
Class I
M04010101 - NON-WOVEN ADHESIVE DRESSINGS, WITH ABSORBENT PAD
Class I
M040204 - NON-ADHERENT ABSORBENT DRESSINGS
Class I
M040299 - NON-ADHESIVE ABSORBENT DRESSINGS - OTHER
Class I
M040301 - EYE PADS, COTTON OR NON-WOVEN MATERIALS
Class I
T0201 - SURGICAL DRAPES
Class I
T020401 - STANDARD SURGICAL GOWNS
Class I
T0205 - NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
Class I
T020699 - MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER
Class I

1 / 2

Certificate G11 097364 0014

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate G11 097364 0014

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer