Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

Certificate DZ 2113818-1

Rev. Rev.2Reissued

Valid until: Mar 30, 2027

Certificate DZ 2113818-1 is a valid Quality assurance issued to Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. and registered in EUDAMED. Valid until March 30, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: DZ 2113818-1
Certificate type: Quality assurance
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197DZ 2113818-1Rev.2

Validity

Issued: Apr 16, 2026
Valid from: Apr 16, 2026
Valid until: Mar 30, 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: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Supersedes

DZ 2113818-1Quality assuranceIssuedMay 9, 2023 → Mar 30, 2027

Scope coverage

Class I1

1 scope

T020604 - MEDICAL USE FACE MASKS, TYPE II AND IIR -Disposable Medical Surgical Masks T0207 - CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) -Disposable Surgical Caps T020401 - STANDARD SURGICAL GOWNS -Disposable Surgical Gowns T010201 - LATEX EXAMINATION / TREATMENT GLOVES -Sterile Latex Examination Gloves for Single Use T020101 - INCISION DRAPES -Disposable Medical Surgical Drapes
Class I

Documents

LanguagesEN