BrosMed Medical Co., Ltd, BrosMed Medical

Certificate HZ 2054277-1

Rev. Rev.4Supplemented

Valid until: Apr 9, 2030

Certificate HZ 2054277-1 is a valid Quality management system issued to BrosMed Medical Co., Ltd, BrosMed Medical and registered in EUDAMED. Valid until April 9, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2054277-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2054277-1Rev.4

Validity

Issued: Jun 12, 2026
Valid from: Jun 12, 2026
Valid until: Apr 9, 2030

Manufacturer

Manufacturer: BrosMed Medical Co., Ltd
Manufacturer SRN: CN-MF-000007501
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

Supplemented

Supersedes

HZ 2054277-1Quality management systemIssuedFeb 9, 2026 → Apr 9, 2030

Scope coverage

Class IIa3Class I1Unspecified1

5 scopes

C0699 - CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER - Balloon Inflation Devices - Balloon Inflation Device Sets C900103 - PERCUTANEOUS ARTERIAL ACCESS HAEMOSTASIS SYSTEMS - Radial Artery Tourniquets C900102 - HAEMOSTASIS ADAPTORS - Y Connector Sets A020104 - SYRINGES FOR INJECTORS, SINGLE-USE - Dose-control Syringes A0280 - SYRINGES - ACCESSORIES - Syringes
Class I
A0703 - STOPCOCKS - Manifolds A030201 - EXTENSIONS - Connecting Tubings - Pressure Connecting Tubings A020104 - SYRINGES FOR INJECTORS, SINGLE-USE - Angiographic Syringes and Accessories A019013 - PERCUTANEOUS NEEDLES - Introducer Needles C0502 - CARDIOVASCULAR INTRODUCER SHEATHS, VALVED - Introducer Sheaths - Pregarde Guiding Sheaths
Class IIa
C04020101 - PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC - Guide Wires - Conger Hydrophilic Guidewires - Conger Plus Hydrophilic Guidewires - Khons Guidewires C04020102 - PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC - Guide Wires C04020201 - PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC - Guide Wires - Conger Hydrophilic Guidewires - Conger Plus Hydrophilic Guidewires
Class IIa
C04020202 - PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC - Guide Wires C0104020204 - PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS - Vasnavi Support Catheters C0104020205 - PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS - Microcatheters V010102 - SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE - Scalpels
Class IIa
SYSTEM_PROCEDURE_PACK

Documents

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