Shandong Shinrise Medical Supplies Co., LTD

Certificate HZ 2438964-1

Rev. 0Issued

Valid until: Nov 21, 2029

Certificate HZ 2438964-1 is a valid Quality management system issued to Shandong Shinrise Medical Supplies Co., LTD and registered in EUDAMED. Valid until November 21, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2438964-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2438964-10

Validity

Issued: Nov 22, 2024
Valid from: Nov 22, 2024
Valid until: Nov 21, 2029

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: Yes
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

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1Class I1

2 scopes

M040402 - ALGINATE DRESSINGS M040403 - HYDROCOLLOID DRESSINGS M040406 - POLYURETHANE DRESSINGS
Class IIa
M010101 - HYDROPHILIC COTTON M040101 - ADHESIVE DRESSINGS, WITH ABSORBENT PAD M040406 - POLYURENTHANE DRESSINGS T020101 - INCISION DRAPES
Class I

Documents

LanguagesEN