INTIN Inc.

Certificate HX 2423456-1

Rev. Rev.0Issued

Valid until: Mar 16, 2030

Certificate HX 2423456-1 is a valid Quality management system issued to INTIN Inc. and registered in EUDAMED. Valid until March 16, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 2423456-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197HX 2423456-1Rev.0

Validity

Issued: Mar 17, 2025
Valid from: Mar 17, 2025
Valid until: Mar 16, 2030

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
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: No
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

IVDR Class B1

1 scope

HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W02020102 - LIMITED PANEL CELL COUNTING ANALYSERS
IVDR Class B

Documents

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