MDR MDR QMS Issued

FI23/00000046

Manufacturer: Rhyk Technologies GmbH
Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Issue 1
109
Expires in 109 days
Expiry: September 26, 2026

Basic Information

Number
FI23/00000046
Type
MDR QMS
Legislation
MDR
Issue Date
September 27, 2023
Expiry Date
September 26, 2026
Revision
Issue 1
Manufacturer
Rhyk Technologies GmbH

Certificate Lifecycle

September 27, 2023 September 26, 2026

Conditions

English

PMCF investigation to be planned and conducted for treatment results that have been obtained with the Rhyk NEO device.

Scopes

2 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIa

EMDN N99 - Nervous and medullary system devices - other

Quality Procedure Scope

Device Class IIa

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.