Jiangsu Vedkang Medical Science and Technology Co., Ltd.

Certificate HZ 2156843-1

Rev. 1Supplemented

Valid until: Nov 21, 2028

Certificate HZ 2156843-1 is a valid Quality management system issued to Jiangsu Vedkang Medical Science and Technology Co., Ltd. and registered in EUDAMED. Valid until November 21, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2156843-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2156843-11

Validity

Issued: Dec 18, 2024
Valid from: Dec 18, 2024
Valid until: Nov 21, 2028

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 2156843-1Quality management systemIssuedNov 22, 2023 → Nov 21, 2028

Scope coverage

Class IIb1Class IIa1Class I1

3 scopes

K020101 - MONO- AND BIPOLAR DEVICES, SINGLE-USE MONO- AND BIPOLAR SURGICAL INSTRUMENTS, SINGLE-USE - Disposable Endoscopic Submucosal Dissection Knives
Class IIb
G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - Gastrointestinal and Biliary Balloon Catheters - 3-Stage Balloon Dilation Catheters G030201 - DIGESTIVE ENDOSCOPY, NEEDLES - Injection Needles G030301 - POLYPECTOMY SNARES - Disposable Cold Snares G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - Disposable Grasping Forceps - Stone Extraction Baskets - Stone Extraction Balloons G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - Disposable Non-electric Biopsy Forceps R070201 - BRONCHOSCOPIC SURGERY FORCEPS, SINGLE-USE - Disposable Non-electric Biopsy Forceps G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER - Non-vascular Guidewires G010102 - CARDIAS DILATATION TUBES - Bougie Dilators
Class IIa
R070207 - BRONCHOSCOPIC SURGERY CANNULAS, SINGLE-USE - Disposable Spray Catheters G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER - Disposable Spray Catheters - Polyp Traps Z120290 - VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - Biopsy Valves G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - Balloon Inflators R070203 - BRONCOPULMONARY ENDOSCOPY BRUSHES, SINGLE-USE - Disposable Cytology Brushes G030803 - GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - Disposable Cytology Brushes
Class I

Documents

LanguagesEN

Scope coverage

Class IIb1Class IIa1Class I1

3 scopes

K020101 - MONO- AND BIPOLAR DEVICES, SINGLE-USE MONO- AND BIPOLAR SURGICAL INSTRUMENTS, SINGLE-USE - Disposable Endoscopic Submucosal Dissection Knives
Class IIb
G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - Gastrointestinal and Biliary Balloon Catheters - 3-Stage Balloon Dilation Catheters G030201 - DIGESTIVE ENDOSCOPY, NEEDLES - Injection Needles G030301 - POLYPECTOMY SNARES - Disposable Cold Snares G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - Disposable Grasping Forceps - Stone Extraction Baskets - Stone Extraction Balloons G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - Disposable Non-electric Biopsy Forceps R070201 - BRONCHOSCOPIC SURGERY FORCEPS, SINGLE-USE - Disposable Non-electric Biopsy Forceps G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER - Non-vascular Guidewires G010102 - CARDIAS DILATATION TUBES - Bougie Dilators
Class IIa
R070207 - BRONCHOSCOPIC SURGERY CANNULAS, SINGLE-USE - Disposable Spray Catheters G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER - Disposable Spray Catheters - Polyp Traps Z120290 - VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - Biopsy Valves G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - Balloon Inflators R070203 - BRONCOPULMONARY ENDOSCOPY BRUSHES, SINGLE-USE - Disposable Cytology Brushes G030803 - GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - Disposable Cytology Brushes
Class I

Certificate HZ 2156843-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HZ 2156843-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer