B·R·A·H·M·S GmbH

Certificat HX 1333941-1

Rév. Rev. 6Restreint

Valide jusqu'au: 20 mars 2028

Le certificat HX 1333941-1 est un certificat Système de management de la qualité valide délivré à B·R·A·H·M·S GmbH et enregistré dans EUDAMED. Valable jusqu'au 20 mars 2028. Consultez la fiche complète du certificat sur MD Atlas.

Aperçu

Numéro de certificat: HX 1333941-1
Type de certificat: Système de management de la qualité
Statut du certificat: Restreint
Législation applicable: IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]
Version: 5
Identifiant du certificat: 0197HX 1333941-1Rev. 6

Validité

Délivré le: 12 nov. 2025
Valide à partir du: 12 nov. 2025
Valide jusqu'au: 20 mars 2028

Organisme notifié

Organisme notifié: TÜV Rheinland LGA Products GmbH
SRN de l'organisme notifié: 0197
Pays de l'organisme notifié: Allemagne

Dispositifs couverts

Aucun dispositif spécifique n'est listé pour ce certificat.

Caractéristiques

Stérile: Non
Tissus humains: Non
Tissus animaux: Non
Diagnostic in vitro: —
Enregistrement initial: Non
Dispositif nouveau: Non
Élimination autorisée: Non
RSCP activé: Oui
Mécanisme de contrôle: Non
Destination médicale: —
RSCP applicable: —
Conditions applicables: Non
MOS hors EUDAMED: Non
Type SMQ/MOS: Autres

Historique

Changements de statut

Restreint

Remplace

HX 1333941-1Système de management de la qualitéComplété14 oct. 2025 → 20 mars 2028

Périmètre de couverture

IVDR Classe C5IVDR Classe B2

7 périmètres

IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020410 - THYROID STIMULATING HORMONE
IVDR Classe B
IVR 608: Devices intended to be used for screening, determination or monitoring of physiological markers W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01020501 - FERTILITY FUNCTION HORMONES / PROTEINS W01020409 - THYROID BINDING GLOBULIN W01020401 - FREE TRIIODOTHYRONINE W01020402 - FREE THYROXINE
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020390 - OTHER TUMOUR MARKERS W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS W01020603 - BONE AND MINERAL METABOLISM ASSAYS
IVDR Classe C
IVR 506: Other devices intended to be used to determine markers of infections/immune status W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01021399 - CARDIAC MARKERS – OTHER
IVDR Classe C
IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021301 - BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER
IVDR Classe C
IVR 0601: Devices intended to be used for screening/confirmation of specific disorders/impairments W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
IVDR Classe C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01030609 - INTERLEUKIN 6 (IL-6) W01030608 - CYTOKINES CALIBRATORS/CONTROLS
IVDR Classe C

Documents

LanguesEN

Périmètre de couverture

IVDR Classe C5IVDR Classe B2

7 périmètres

IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020410 - THYROID STIMULATING HORMONE
IVDR Classe B
IVR 608: Devices intended to be used for screening, determination or monitoring of physiological markers W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020604 - ENDOCRINE HORMONES AND PEPTIDES W01020501 - FERTILITY FUNCTION HORMONES / PROTEINS W01020409 - THYROID BINDING GLOBULIN W01020401 - FREE TRIIODOTHYRONINE W01020402 - FREE THYROXINE
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 301: Devices intended to be used in screening, diagnosis, staging or monitoring of cancer W01020301 - CANCER ANTIGENS W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020390 - OTHER TUMOUR MARKERS W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS W01020603 - BONE AND MINERAL METABOLISM ASSAYS
IVDR Classe C
IVR 506: Other devices intended to be used to determine markers of infections/immune status W01021520 - CONTROLS - IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020690 - VARIOUS INDIVIDUAL AND SPECIFIC HORMONES W01021399 - CARDIAC MARKERS – OTHER
IVDR Classe C
IVR 602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01021301 - BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01021003 - THYROID-AUTO-IMMUNE DISEASE W01020499 - THYROID HORMONES – OTHER
IVDR Classe C
IVR 0601: Devices intended to be used for screening/confirmation of specific disorders/impairments W01021520 - CONTROLS – IMMUNOCHEMISTRY W01021522 - STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY W01020502 - PREGNANCY TESTING HORMONES / PROTEINS W01021521 - MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
IVDR Classe C
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0506: Other devices intended to be used to determine markers of infections/immune status W01030609 - INTERLEUKIN 6 (IL-6) W01030608 - CYTOKINES CALIBRATORS/CONTROLS
IVDR Classe C

Certificat HX 1333941-1

Aperçu

Validité

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Certificat HX 1333941-1

Aperçu

Validité

Fabricant

Organisme notifié

Dispositifs couverts

Caractéristiques

Historique

Changements de statut

Remplace

Périmètre de couverture

Documents

Fabricant