One Lambda, Inc.

Certificate HX 2233216-1

Rev. 0Issued

Valid until: Oct 28, 2030

Certificate HX 2233216-1 is a valid Quality management system issued to One Lambda, Inc. and registered in EUDAMED. Valid until October 28, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 2233216-1
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 2233216-10

Validity

Issued: Oct 29, 2025
Valid from: Oct 29, 2025
Valid until: Oct 28, 2030

Manufacturer

Manufacturer: One Lambda, Inc.
Manufacturer SRN: US-MF-000024901
Manufacturer country: United States

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

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class C1

1 scope

HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0201: Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration W01030402 - HLA ANTIBODY SCREENING W01030403 - HLA ANTIGEN TYPING
IVDR Class C

Documents

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