MDR MDR QMS Issued

HZ 2090547-1

Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
1
Revision
0
1310
Valid for 1310 days
Expiry: January 9, 2030

Basic Information

Number
HZ 2090547-1
Type
MDR QMS
Legislation
MDR
Issue Date
January 10, 2025
Expiry Date
January 9, 2030

Certificate Lifecycle

January 10, 2025 January 9, 2030

Device Characteristics

Sterile

Scopes

Quality Procedure Scope

Device Group Class I Sterile

R070203 - BRONCOPULMONARY ENDOSCOPY BRUSHES, SINGLE-USE - Disposable Cytology Brushes The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions Products of class IIa: K010101 - TROCAR, SINGLE-USE - Disposable Laparoscopic Trocars K010102 - MINIMALLY INVASIVE SURGERY KITS, SINGLEUSE - Disposable Laparoscopic Trocar Kits K010201 - MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENTS, SINGLE-USE - Disposable Retrieval Bags - Disposable Incision Protectors G020401 - HAEMORRHOID LIGATURE SETS - Disposable Anorectal Ligation Devices and Cartridges G020499 - GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER - Elastic Threads - Rubber Rings G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - Disposable Grasping Forceps - Disposable Biopsy Forceps H020101 - MECHANICAL SKIN STAPLERS - Disposable Skin Staplers - Disposable Circumcision Staplers

Basic UDI-DIs

This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.