Leica Biosystems Newcastle Ltd

Certificate IVDR 739320

Rev. R001Reissued

Valid until: Jun 7, 2031

Certificate IVDR 739320 is a valid Quality management system issued to Leica Biosystems Newcastle Ltd and registered in EUDAMED. Valid until June 7, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: IVDR 739320
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 2797IVDR 739320R001

Validity

Issued: Jun 1, 2026
Valid from: Jun 8, 2026
Valid until: Jun 7, 2031

Manufacturer

Manufacturer: Leica Biosystems Newcastle Ltd
Manufacturer SRN: GB-MF-000020595
Manufacturer country: United Kingdom

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

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

Supersedes

IVDR 739320SupplementedSep 16, 2024 → Jun 7, 2026

Predecessor certificate not registered in EUDAMED.

Scope coverage

IVDR Class C5IVDR Class B2

7 scopes

W0103 - Haematology / Haemostasis / Immunohaematology / Histology / Cytology IVP3007 – In vitro diagnostics which require a knowledge of Immunoassays
IVDR Class C
IVR0702 - Devices which are controls without a qualitative assigned value
IVDR Class B
Leica HER2 FISH Control Slides
IVDR Class C
W0103 - Haematology / Haemostasis / Immunohematology / Histology / Cytology IVP3011 – In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS)
IVDR Class C
Leica HER2 FISH System
IVDR Class C
Bond Oracle HER2 IHC System
IVDR Class C
IVR0604 - Other devices intended to be used for a specific disease
IVDR Class B

Documents

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