GenBody Inc.

Certificate HX 2631406-1

Rev. 1Supplemented

Valid until: Oct 1, 2030

Certificate HX 2631406-1 is a valid Quality management system issued to GenBody Inc. and registered in EUDAMED. Valid until October 1, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 2631406-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197HX 2631406-11

Validity

Issued: May 11, 2026
Valid from: May 11, 2026
Valid until: Oct 1, 2030

Manufacturer

Manufacturer: GenBody Inc.
Manufacturer SRN: KR-MF-000043626
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

Status changes

Supplemented

Supersedes

HX 2631406-1IssuedOct 2, 2025 → Oct 1, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

IVDR Class B1IVDR Class C1

2 scopes

Products of class B, near-patient testing: HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01030105 - HAEMATOLOGY CONTROLS AND CALIBRATORS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W02029099 - VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER
IVDR Class B
Products of class C, self-testing: CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS IVR 0602: Physiological markers for a specific disease W02010601 - DIABETES MONITORING CLINICAL CHEMISTRY IVR 0602: Physiological markers for a specific disease W01010601 - BLOOD TEST STRIPS (CC) - RT & POC
IVDR Class C

Documents

LanguagesEN