EUROIMMUN Medizinische Labordiagnostika AG

Certificate HX 1483000-1

Rev. Rev. 10Supplemented

Valid until: May 9, 2028

Certificate HX 1483000-1 is a valid Quality management system issued to EUROIMMUN Medizinische Labordiagnostika AG and registered in EUDAMED. Valid until May 9, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 1483000-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 11
Certificate ID: 0197HX 1483000-1Rev. 10

Validity

Issued: Mar 6, 2026
Valid from: Mar 6, 2026
Valid until: May 9, 2028

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: No
QMS/MOS type: Others

History

Status changes

Supplemented
Supplemented

Supersedes

HX 1483000-1Quality management systemSupplementedJan 21, 2026 → May 9, 2028

Scope coverage

IVDR Class C8IVDR Class B7IVDR Class D1

16 scopes

IVR 0602: IMMUNOCHEMISTRY (IMMUNOLOGY) W01021004 - VASCULITIS W01021090 - VARIOUS AUTO-IMMUNE DISEASE
IVDR Class C
IVR 0602: IMMUNOCHEMISTRY (IMMUNOLOGY) W01020190 – OTHER SPECIFIC PROTEINS W01021001 - AUTOIMMUNE CONNECTIVE TISSUE DISEASES W01021090 - VARIOUS AUTO-IMMUNE DISEASE W01021112 - ANTI-CYCLIC CITRULLINATED PEPTIDE W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021199 - RHEUMATOID / INFLAMMATORY DISEASE MARKERS – OTHER W01021002 - NEURO-AUTO-IMMUNE DISEASE W01021005 – ANTI-PHOSPHOLIPID SYNDROM
IVDR Class B
IVR 0603: Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances W01020201 - IMMUNOGLOBULIN E – TOTAL W01020204 - IMMUNOGLOBULIN E – MONOTEST/PLURIRESULT-MULTI AG
IVDR Class B
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020190 - OTHER SPECIFIC PROTEINS W01020702 - VITAMINES W01021520 - CONTROLS – IMMUNOCHEMISTRY W01029099 - IMMUNOCHEMISTRY REAGENTS - OTHER
IVDR Class B
IVR 0503: INFECTIOUS DISEASES W01050101 - CHLAMYDIA W01050106 - LYME BORRELIOSIS W01050117 - OTHER BACTERIOLOGY IMMUNOASSAYS W01050404 - EPSTEIN BARR VIRUS W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050407 - MEASLES VIRUS W01050502 - MISCELLANEOUS PARASITOLOGY W01050808 - CONTROLS - INFECT. IMMUNOLOGY
IVDR Class B
IVR 0504: Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging W01050117 - OTHER BACTERIOLOGY IMMUNOASSAYS
IVDR Class B
IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W0201020192 - AUTOMATED IMMUNOCHEMISTRY ANALYSERS – IVD MEDICAL DEVICE SOFTWARE
IVDR Class B
IVR 0501: INFECTIOUS DISEASES W01050402 - CYTOMEGALOVIRUS W01050501 - TOXOPLASMA W01050401 - RUBELLA VIRUS W01050101 - CHLAMYDIA
IVDR Class C
IVR 0503: INFECTIOUS DISEASES W01050405 - OTHER VIROLOGY - NA REAGENTS W01050107 - MYCOBACTERIA GENUS + SPECIES
IVDR Class C
IVR 0402: GENETIC TESTING W01060101 - MONOGENETIC DISORDERS
IVDR Class C
IVR 0402: NUCLEIC ACID TESTING INSTRUMENTS W02050292 - MICRO-ARRAY INSTRUMENTS – IVD MEDICAL DEVICE SOFTWARE
IVDR Class C
IVR 0501: CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS W0201020192 - AUTOMATED IMMUNOCHEMISTRY ANALYSERS – IVD MEDICAL DEVICE SOFTWARE
IVDR Class C
IVR 0503: INFECTIOUS DISEASES W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION Remove since 2025-06-13
IVDR Class D
IVR 0503: INFECTIOUS DISEASES W01050101 - CHLAMYDIA W01050103 – SYPHILIS (TREPONEMA PALLIDUM) W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050409 – VARICELLA ZOSTER VIRUS W01050501 - TOXOPLASMA W01050604 - MYCOLOGY - NA REAGENTS
IVDR Class C
IVR 0602: IMMUNOCHEMISTRY (IMMUNOLOGY) W01020190 - OTHER SPECIFIC PROTEINS
IVDR Class B
IVR 0503: INFECTIOUS DISEASES - remove since 2026-03-06 W01050405 - OTHER VIROLOGY - NA REAGENTS W01050107 - MYCOBACTERIA GENUS + SPECIES
IVDR Class C

Documents

LanguagesEN

Scope coverage

IVDR Class C8IVDR Class B7IVDR Class D1

16 scopes

IVR 0602: IMMUNOCHEMISTRY (IMMUNOLOGY) W01021004 - VASCULITIS W01021090 - VARIOUS AUTO-IMMUNE DISEASE
IVDR Class C
IVR 0602: IMMUNOCHEMISTRY (IMMUNOLOGY) W01020190 – OTHER SPECIFIC PROTEINS W01021001 - AUTOIMMUNE CONNECTIVE TISSUE DISEASES W01021090 - VARIOUS AUTO-IMMUNE DISEASE W01021112 - ANTI-CYCLIC CITRULLINATED PEPTIDE W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021199 - RHEUMATOID / INFLAMMATORY DISEASE MARKERS – OTHER W01021002 - NEURO-AUTO-IMMUNE DISEASE W01021005 – ANTI-PHOSPHOLIPID SYNDROM
IVDR Class B
IVR 0603: Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances W01020201 - IMMUNOGLOBULIN E – TOTAL W01020204 - IMMUNOGLOBULIN E – MONOTEST/PLURIRESULT-MULTI AG
IVDR Class B
IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01020190 - OTHER SPECIFIC PROTEINS W01020702 - VITAMINES W01021520 - CONTROLS – IMMUNOCHEMISTRY W01029099 - IMMUNOCHEMISTRY REAGENTS - OTHER
IVDR Class B
IVR 0503: INFECTIOUS DISEASES W01050101 - CHLAMYDIA W01050106 - LYME BORRELIOSIS W01050117 - OTHER BACTERIOLOGY IMMUNOASSAYS W01050404 - EPSTEIN BARR VIRUS W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050407 - MEASLES VIRUS W01050502 - MISCELLANEOUS PARASITOLOGY W01050808 - CONTROLS - INFECT. IMMUNOLOGY
IVDR Class B
IVR 0504: Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging W01050117 - OTHER BACTERIOLOGY IMMUNOASSAYS
IVDR Class B
IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W0201020192 - AUTOMATED IMMUNOCHEMISTRY ANALYSERS – IVD MEDICAL DEVICE SOFTWARE
IVDR Class B
IVR 0501: INFECTIOUS DISEASES W01050402 - CYTOMEGALOVIRUS W01050501 - TOXOPLASMA W01050401 - RUBELLA VIRUS W01050101 - CHLAMYDIA
IVDR Class C
IVR 0503: INFECTIOUS DISEASES W01050405 - OTHER VIROLOGY - NA REAGENTS W01050107 - MYCOBACTERIA GENUS + SPECIES
IVDR Class C
IVR 0402: GENETIC TESTING W01060101 - MONOGENETIC DISORDERS
IVDR Class C
IVR 0402: NUCLEIC ACID TESTING INSTRUMENTS W02050292 - MICRO-ARRAY INSTRUMENTS – IVD MEDICAL DEVICE SOFTWARE
IVDR Class C
IVR 0501: CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS W0201020192 - AUTOMATED IMMUNOCHEMISTRY ANALYSERS – IVD MEDICAL DEVICE SOFTWARE
IVDR Class C
IVR 0503: INFECTIOUS DISEASES W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION Remove since 2025-06-13
IVDR Class D
IVR 0503: INFECTIOUS DISEASES W01050101 - CHLAMYDIA W01050103 – SYPHILIS (TREPONEMA PALLIDUM) W01050406 - OTHER VIROLOGY ANTIGEN/ANTIBODY DETECTION W01050409 – VARICELLA ZOSTER VIRUS W01050501 - TOXOPLASMA W01050604 - MYCOLOGY - NA REAGENTS
IVDR Class C
IVR 0602: IMMUNOCHEMISTRY (IMMUNOLOGY) W01020190 - OTHER SPECIFIC PROTEINS
IVDR Class B
IVR 0503: INFECTIOUS DISEASES - remove since 2026-03-06 W01050405 - OTHER VIROLOGY - NA REAGENTS W01050107 - MYCOBACTERIA GENUS + SPECIES
IVDR Class C

Certificate HX 1483000-1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate HX 1483000-1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer