Hicren (Zhejiang) Medtech Co., Ltd.

Certificate HZ 2138909-1

Rev. Rev.1Amended

Valid until: Dec 17, 2029

Certificate HZ 2138909-1 is a valid Quality management system issued to Hicren (Zhejiang) Medtech Co., Ltd. and registered in EUDAMED. Valid until December 17, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2138909-1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2138909-1Rev.1

Validity

Issued: Jun 3, 2026
Valid from: Jun 3, 2026
Valid until: Dec 17, 2029

Manufacturer

Manufacturer: Hicren (Zhejiang) Medtech Co., Ltd.
Manufacturer SRN: CN-MF-000025999
Manufacturer country: China

Notified body

Notified body
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

History

Status changes

Amended

Supersedes

HZ 2138909-1Quality management systemIssuedDec 18, 2024 → Dec 17, 2029

Scope coverage

Class I1Class IIa1

2 scopes

P099002 - ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS - Location Plates - Inflation Devices - Bone Cement Mixing Sets
Class I
P099002 - ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS - Percutaneous Access Needles - Guide Wires - Dilators - Bone Drills - Balloon Catheters - Bone Cement Delivery Cannulas
Class IIa

Documents

LanguagesEN