biocyc Biotechnologie GmbH & Co. KG

Certificate HX 1108389-1

Rev. Rev.0Issued

Valid until: Jun 20, 2029

Certificate HX 1108389-1 is a valid Quality management system issued to biocyc Biotechnologie GmbH & Co. KG and registered in EUDAMED. Valid until June 20, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1108389-1
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 1108389-1Rev.0

Validity

Issued: Jun 21, 2024
Valid from: Jun 21, 2024
Valid until: Jun 20, 2029

Manufacturer

Manufacturer: biocyc Biotechnologie GmbH & Co. KG
Manufacturer SRN: DE-MF-000031533
Manufacturer country: Germany

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: Yes
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 C1

1 scope

HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01030709 - PRIMARY ANTISERA FOR IMMUNOHISTOLOGY
IVDR Class C

Documents

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