GenBody Inc.

Certificate IX 2631406-1

Rev. Rev.0Issued

Valid until: Oct 1, 2030

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

Overview

Certificate number: IX 2631406-1
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 2631406-1Rev.0

Validity

Issued: Oct 2, 2025
Valid from: Oct 2, 2025
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

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class B2

2 scopes

Hemonitor H1
IVDR Class B
88000767HMGA101G2
Hemonitor H1 Control Set
IVDR Class B
88000767HMCT001JN

Documents

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