Innovex Medical Co., Ltd.

Certificate HZ 2108739-1

Rev. Rev.3Supplemented

Valid until: Sep 21, 2028

Certificate HZ 2108739-1 is a valid Quality management system issued to Innovex Medical Co., Ltd. and registered in EUDAMED. Valid until September 21, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2108739-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 2108739-1Rev.3

Validity

Issued: Feb 9, 2026
Valid from: Feb 9, 2026
Valid until: Sep 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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

HZ 2108739-1Quality management systemSupplementedJun 10, 2025 → Sep 21, 2028

Scope coverage

Class IIa2Class I1

3 scopes

A0699-DRAINAGE AND FLUID COLLECTION DEVICES - OTHER - Urological Sampler Sets U090301 - FORCEPS FOR UROGENITAL ENDOSCOPY, SINGLE-USE - Single Use Grasping Forceps
Class I
U020199 - URETERAL CATHETERS WITHOUT BALLOON – OTHER - Ureteral Access Sheaths - Ureteral Catheters U030202 - URETERAL DILATORS, WITH BALLOON - Ureteral Dilation Balloon Catheters U0601 - UROLOGICAL GUIDEWIRES, HYDROPHILIC - Urological Guidewires U0602 - UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC - Urological Guidewires U090101 - URINARY STONE RETRIEVAL BASKETS - Urological Stone Extraction Baskets
Class IIa
U020302 - DOUBLE LOOP URETERAL STENTS - Ureteral Stents R010499 - ENDOBRONCHIAL TUBES - OTHER - Endobronchial Blocker Catheters U030102 - URETHRAL AND URETERAL DILATORS - Ureteral Dilator Sets - Urethral Dilator Sets
Class IIa

Documents

LanguagesEN

Scope coverage

Class IIa2Class I1

3 scopes

A0699-DRAINAGE AND FLUID COLLECTION DEVICES - OTHER - Urological Sampler Sets U090301 - FORCEPS FOR UROGENITAL ENDOSCOPY, SINGLE-USE - Single Use Grasping Forceps
Class I
U020199 - URETERAL CATHETERS WITHOUT BALLOON – OTHER - Ureteral Access Sheaths - Ureteral Catheters U030202 - URETERAL DILATORS, WITH BALLOON - Ureteral Dilation Balloon Catheters U0601 - UROLOGICAL GUIDEWIRES, HYDROPHILIC - Urological Guidewires U0602 - UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC - Urological Guidewires U090101 - URINARY STONE RETRIEVAL BASKETS - Urological Stone Extraction Baskets
Class IIa
U020302 - DOUBLE LOOP URETERAL STENTS - Ureteral Stents R010499 - ENDOBRONCHIAL TUBES - OTHER - Endobronchial Blocker Catheters U030102 - URETHRAL AND URETERAL DILATORS - Ureteral Dilator Sets - Urethral Dilator Sets
Class IIa

Certificate HZ 2108739-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HZ 2108739-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer