Dr. Fooke-Achterrath Laboratorien GmbH

Certificate D1060800025

Issued

Valid until: Jun 10, 2031

Certificate D1060800025 is a valid Quality management system issued to Dr. Fooke-Achterrath Laboratorien GmbH and registered in EUDAMED. Valid until June 10, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: D1060800025
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: 0483D1060800025

Validity

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

Manufacturer

Manufacturer: Dr. Fooke-Achterrath Laboratorien GmbH
Manufacturer SRN: DE-MF-000024189
Manufacturer country: Germany

Notified body

Notified body
Notified body SRN: 0483
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

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class B1

1 scope

Immunoassay intended to be used to define or monitor physiological status and therapeutic measures
IVDR Class B

Documents

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