Institut Virion\Serion GmbH

Certificate HX 1098896-1

Rev. Rev.1Cancelled

Valid until: May 15, 2029

Certificate HX 1098896-1, a Quality management system issued to Institut Virion\Serion GmbH, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1098896-1
Certificate type: Quality management system
Certificate status: Cancelled
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 3
Certificate ID: 0197HX 1098896-1Rev.1

Validity

Issued: Feb 12, 2025
Valid from: Feb 12, 2025
Valid until: May 15, 2029

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: No
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

Status changes

Cancelled

Supersedes

HX 1098896-1Quality management systemSupplementedFeb 12, 2025 → May 15, 2029

Scope coverage

IVDR Class C2IVDR Class B1

3 scopes

INFECTIOUS DISEASES IVR 0501 W01050401 - RUBELLA VIRUS W01050402 - CYTOMEGALOVIRUS W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050409 - VARICELLA ZOSTER VIRUS W01050501 - TOXOPLASMA W01050808 – CONTROLS INFECTIOUS IMMUNOLOGY
IVDR Class C
INFECTIOUS DISEASES IVR 0503 W01050101 - CHLAMYDIA W01050402 - CYTOMEGALOVIRUS W01050403 - HERPES SIMPLEX VIRUS W01050603 - MYCOLOGY IMMUNOASSAYS W01050808 – CONTROLS INFECTIOUS IMMUNOLOGY
IVDR Class C
INFECTIOUS DISEASES IVR 0503 W01050101 - CHLAMYDIA W01050104 - HELICOBACTER PYLORI W01050105 - LEGIONELLA W01050106 - LYME BORRELIOSIS W01050108 - MYCOPLASMA W01050117 - OTHER BACTERIOLOGY IMMUNOASSAYS W01050404 - EPSTEIN BARR VIRUS W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050407 - MEASLES VIRUS W01050408 - MUMPS / PAROTITIS VIRUS W01050502 - MISCELLANEOUS PARASITOLOGY W01050603 - MYCOLOGY IMMUNOASSAYS W01050808 - CONTROLS - INFECT. IMMUNOLOGY W01059002 - OTHER INFECTIOUS IMMUNOLOGY REAGENTS
IVDR Class B

Documents

LanguagesEN

Scope coverage

IVDR Class C2IVDR Class B1

3 scopes

INFECTIOUS DISEASES IVR 0501 W01050401 - RUBELLA VIRUS W01050402 - CYTOMEGALOVIRUS W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050409 - VARICELLA ZOSTER VIRUS W01050501 - TOXOPLASMA W01050808 – CONTROLS INFECTIOUS IMMUNOLOGY
IVDR Class C
INFECTIOUS DISEASES IVR 0503 W01050101 - CHLAMYDIA W01050402 - CYTOMEGALOVIRUS W01050403 - HERPES SIMPLEX VIRUS W01050603 - MYCOLOGY IMMUNOASSAYS W01050808 – CONTROLS INFECTIOUS IMMUNOLOGY
IVDR Class C
INFECTIOUS DISEASES IVR 0503 W01050101 - CHLAMYDIA W01050104 - HELICOBACTER PYLORI W01050105 - LEGIONELLA W01050106 - LYME BORRELIOSIS W01050108 - MYCOPLASMA W01050117 - OTHER BACTERIOLOGY IMMUNOASSAYS W01050404 - EPSTEIN BARR VIRUS W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050407 - MEASLES VIRUS W01050408 - MUMPS / PAROTITIS VIRUS W01050502 - MISCELLANEOUS PARASITOLOGY W01050603 - MYCOLOGY IMMUNOASSAYS W01050808 - CONTROLS - INFECT. IMMUNOLOGY W01059002 - OTHER INFECTIOUS IMMUNOLOGY REAGENTS
IVDR Class B

Certificate HX 1098896-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HX 1098896-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer