Promisemed Hangzhou Meditech Co., Ltd.

Certificat HZ 2091024-1

Rév. Rev.13Complété

Valide jusqu'au: 13 nov. 2030

Le certificat HZ 2091024-1 est un certificat Système de management de la qualité valide délivré à Promisemed Hangzhou Meditech Co., Ltd. et enregistré dans EUDAMED. Valable jusqu'au 13 novembre 2030. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: HZ 2091024-1
Type de certificat: Système de management de la qualité
Statut du certificat: Complété
Législation applicable: MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]
Version: 5
Identifiant du certificat: 0197HZ 2091024-1Rev.13

Validité

Délivré le: 8 juin 2026
Valide à partir du: 8 juin 2026
Valide jusqu'au: 13 nov. 2030

Fabricant

Fabricant: Promisemed Hangzhou Meditech Co., Ltd.
SRN du fabricant: CN-MF-000008465
Pays du fabricant: Chine

Organisme notifié

Organisme notifié
SRN de l'organisme notifié: 0197
Pays de l'organisme notifié: Allemagne

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

Stérile: Oui
Tissus humains: Non
Tissus animaux: Non
Diagnostic in vitro: Non
Enregistrement initial: Non
Dispositif nouveau: Non
Élimination autorisée: Non
RSCP activé: Oui
Mécanisme de contrôle: Oui
Destination médicale: Non
RSCP applicable

Historique

Changements de statut

Complété

Remplace

HZ 2091024-1Système de management de la qualitéComplété2 avr. 2026 → 13 nov. 2030

Périmètre de couverture

Classe IIa6Classe I2Classe IIb1

9 périmètres

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
Classe 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
Classe 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
Classe 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
Classe 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
Classe 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
Classe 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
Classe IIa
D0702 - ISOPROPYL ALCOHOL FOR THE DISINFECTION OF MEDICAL DEVICES - Alcohol Swabs
Classe 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
Classe IIb

Documents

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