Promisemed Hangzhou Meditech Co., Ltd.

Certificate HZ 2091024-1

Rev. Rev.13Supplemented

Valid until: Nov 13, 2030

Certificate HZ 2091024-1 is a valid Quality management system issued to Promisemed Hangzhou Meditech Co., Ltd. and registered in EUDAMED. Valid until November 13, 2030. 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: 5
Certificate ID: 0197HZ 2091024-1Rev.13

Validity

Issued: Jun 8, 2026
Valid from: Jun 8, 2026
Valid until: Nov 13, 2030

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 systemSupplementedApr 2, 2026 → Nov 13, 2030

Scope coverage

Class IIa6Class I2Class IIb1

9 scopes

A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE - Sterile Syringes without Needles A070103 - INFUSION LINES ADAPTERS AND CONNECTORS - Needleless Adapters A019001 - BLUNT NEEDLES - Blunt Needles A010180 - NEEDLES FOR INFUSION AND COLLECTION - ACCESSORIES - Blood Collection Tube Holders
Class I
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 U0601 - UROLOGICAL GUIDEWIRES, HYDROPHILIC & R070299 - BRONCHOSCOPIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER & G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER - Endoscopic Guidewires
Class I
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
Class IIa
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 - Endoscopic Ultrasound Needles - Full Core Biopsy Needles A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE - Safety Sterile Syringes - Sterile Syringes with Fixed Needles
Class IIa
A020106 - INSULIN SYRINGES, SINGLE-USE - Insulin Syringes - Safety Insulin Syringes - Safety Sterile 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
Class IIa
V010402 - LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE - Blood Lancets G030201 - DIGESTIVE ENDOSCOPY, NEEDLES - Endoscopic Injection Needles G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE & R070201 - BRONCHOSCOPIC SURGERY FORCEPS, SINGLE-USE & U090301 - FORCEPS FOR UROGENITAL ENDOSCOPY, SINGLE-USE - Single Use Biopsy Forceps G030301 - POLYPECTOMY SNARES - Cold Polypectomy Snares
Class IIa
U090101 - URINARY STONE RETRIEVAL BASKETS & G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - Stone Retrieval Baskets U030102 - URETHRAL AND URETERAL DILATORS - Ureteral Access Sheaths Z120208 - PULMONARY ENDOSCOPIC INSTRUMENTS - Single-use Flexible Bronchoscopes Z120205 - UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS - Single-use Flexible Choledochoscopes Z120207 - GENITOURINARY ENDOSCOPY INSTRUMENTS - Single-use Flexible Ureteroscopes - Single-use Flexible Cystoscopes
Class IIa
D0702 - ISOPROPYL ALCOHOL FOR THE DISINFECTION OF MEDICAL DEVICES - Alcohol Swabs
Class IIa
G030202 - DIGESTIVE ENDOSCOPY, HAEMOSTASIS DEVICES DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS - Single Use Hemoclips G030301 - POLYPECTOMY DEVICES POLYPECTOMY SNARES - Polypectomy Snares G030801 - GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, SINGLE-USE INSTRUMENTS GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - Hot Biopsy Forceps
Class IIb

Documents

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