GENMED ENTERPRISES INTERNATIONAL LTD

Certificate DZ 2318749-1

Rev. 2Supplemented

Valid until: Jan 20, 2027

Certificate DZ 2318749-1 is a valid Quality assurance issued to GENMED ENTERPRISES INTERNATIONAL LTD and registered in EUDAMED. Valid until January 20, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: DZ 2318749-1
Certificate type: Quality assurance
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197DZ 2318749-12

Validity

Issued: Aug 29, 2025
Valid from: Aug 29, 2025
Valid until: Jan 20, 2027

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: —
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

DZ 2318749-1Quality assuranceIssuedFeb 9, 2022 → Jan 20, 2027

Scope coverage

Class IIa1

1 scope

K010101 - TROCAR, SINGLE USE - Sterile Trocars for Single Use K0104 - VERESS NEEDLES - Sterile Insufflation Needles for Single Use K010201 - MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE - Sterile Suction Irrigations for Single Use - Sterile Specimen Retrieval Bags for Single Use - Sterile Wound Protector for Single Use
Class IIa

Documents

LanguagesEN