GenBody Inc.

Certificate IX 2631406-2

Rev. 0Issued

Valid until: May 10, 2031

Certificate IX 2631406-2 is a valid Technical documentation issued to GenBody Inc. and registered in EUDAMED. Valid until May 10, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: IX 2631406-2
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197IX 2631406-20

Validity

Issued: May 11, 2026
Valid from: May 11, 2026
Valid until: May 10, 2031

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Characteristics

Sterile: —
Human tissues: —
Animal tissues: —
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable: —
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Unspecified4

4 scopes

ConfiGlu G1 Blood Glucose Meter Set
88000767BGMGS001PX
ConfiGlu G1 Blood Glucose Test Strip
88000767BGSG001FP
ConfiGlu G1 Glucose Control solution
88000767BGC0028H
ConfiGlu G1 Glucose Control Solution
88000767BGC0038K

Documents

LanguagesEN