MDR MDR QMS Supplemented

CSQ0001220223

Manufacturer: BETATEX SPA
Basic UDI-DIs
0
Scopes
11
Preceding Certs
1
Risk Classes
2
Characteristics
1
Revision
02
502
Valid for 502 days
Expiry: October 23, 2027

Basic Information

Number
CSQ0001220223
Type
MDR QMS
Legislation
MDR
Issue Date
February 13, 2023
Expiry Date
October 23, 2027
Revision
02
Manufacturer
BETATEX SPA

Certificate Lifecycle

February 13, 2023 October 23, 2027

Device Characteristics

Sterile

Scopes

11 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class I Sterile

ABBIGLIAMENTO, TELERIA STANDARD E TELERIA SPECIALISTICA CLOTHING, STANDARD AND SPECIALIST DRAPERY Abbigliamento Clothing Teleria Standard Standard Drapery Teleria Termica Thermal Drapery Teleria Specialistica Specialist Drapery

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Group Class IIb

Kit per Cateterismo Vescicale Bladder Catheterisation Kits

Quality Procedure Scope

System Procedure Pack

Quality Procedure Scope

Device Group Class I Sterile

KIT E SET PER SALA OPERATORIA, STRUMENTARIO E COMPONENTISTICA

Quality Procedure Scope

Device Class I Sterile

Quality Procedure Scope

Device Class I Sterile

Quality Procedure Scope

Device Class I Sterile

Quality Procedure Scope

Device Group Class IIb

Siringhe Preriempite Syringes

Quality Procedure Scope

Device Class I Sterile

Quality Procedure Scope

Device Class I Sterile

Preceding Certificates

CSQ0001220122 Supplemented
Issued: November 30, 2022 Expires: October 23, 2027

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.