Promisemed Hangzhou Meditech Co., Ltd.

Certificate HZ 2091024-1

Rev. 7Supplemented

Valid until: Nov 13, 2025

Certificate HZ 2091024-1, a Quality management system issued to Promisemed Hangzhou Meditech Co., Ltd., has expired. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2091024-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 2091024-17

Validity

Issued: Oct 23, 2024
Valid from: Oct 23, 2024
Valid until: Nov 13, 2025

Manufacturer

Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.
Manufacturer SRN: CN-MF-000008465
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: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

HZ 2091024-1Quality management systemSupplementedJun 20, 2024 → Nov 13, 2025

Scope coverage

Class IIa1Class I1Class IIb1

3 scopes

A010101 – HYPODERMIC NEEDLES - Insulin Pen Needles - Safety Insulin Pen Needles - Safety Sterile Needles - Sterile Needles A010103 – NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT) - Safety Huber Needles - Regular Huber Needles A010105 – NEEDLES FOR COLLECTION UNDER VACUUM - Safety Winged Blood Collection Sets - Winged Blood Collection Sets A010201 – NEEDLES AND KITS - HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - Co-axial Biopsy Devices - Fine Biopsy Needles - Semi-automatic Biopsy Needles - Automatic Biopsy Needles A010202 – BONE MARROW BIOPSY NEEDLES AND KITS - Bone Marrow Biopsy Needles A020102 – INFUSION AND IRRIGATION SYRINGES, SINGLE-USE - Safety Sterile Syringes - Sterile Syringes with Safety Needle Combo - Sterile Syringes with Fixed Needles - Auto-Disable Syringes A020106 – INSULIN SYRINGES, SINGLE-USE - Insulin Syringes - Safety Insulin Syringes A019012 – BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS - Breast Localization Wires A060201 - EXTERNAL DRAINAGE CATHETERS AND KITS (ABSCESSES, GALLSTONES, CYSTS) - Multipurpose Drainage Catheters V010401 – LANCETS WITH SAFETY SYSTEMS, SINGLE-USE - Heel Blood Lancets - Safety Blood Lancets V010402 – LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE - Blood Lancets G030201 - DIGESTIVE ENDOSCOPY, NEEDLES - Endoscopic Injection Needles G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - Single Use Biopsy Forceps G030301 - POLYPECTOMY SNARES - Cold Polypectomy Snares U090101 –URINARY STONE RETRIEVAL BASKETS G030501 –DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - Stone Retrieval Baskets
Class IIa
A020102 – INFUSION AND IRRIGATION SYRINGES, SINGLE-USE - Sterile Syringes without Needles A070103 – INFUSION LINES ADAPTERS AND CONNECTORS - Needleless Adapters - Heparin Plugs A019001 – BLUNT NEEDLES - Blunt Needles A010180 – NEEDLES FOR INFUSION AND COLLECTION - ACCESSORIES - Blood Collection Tube Holders G030704 – COLON DYE SPRAYING CATHETERS - Spraying Catheters for Single Use G030801 – GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE USE - Single Use Grasping Forceps G030803 – GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - Single Use Cytology Brushes G030501 – DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - Retrieval Nets A030201 –EXTENSIONS - Extension Sets
Class I
G030202 – DIGESTIVE ENDOSCOPY, HAEMOSTASIS DEVICES – DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS - Single Use Hemoclips
Class IIb

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