MDR MDR QA Issued

MDR.2292-2024/0003

Manufacturer: BAMA Teknoloji A.Ş.
Basic UDI-DIs
0
Scopes
4
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
0
1247
Valid for 1247 days
Expiry: November 6, 2029

Basic Information

Number
MDR.2292-2024/0003
Type
MDR QA
Legislation
MDR
Issue Date
November 7, 2024
Expiry Date
November 6, 2029
Manufacturer
BAMA Teknoloji A.Ş.

Certificate Lifecycle

November 7, 2024 November 6, 2029

Scopes

4 scopes covering 1 risk classes

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Group Class IIa

ROBOGAIT VERSION 1.2 WALKING THERAPY SYSTEM

Quality Procedure Scope

Device Group Class IIa

FREEGAIT VERSION 1.0 - EXOSKELETON DEVICE AND ITS ACCESSORIES

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.