IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]
Version
2
Identifiant du certificat
0197HX 1695779-1Rev. 2
Validité
Délivré le
25 févr. 2026
Valide à partir du
25 févr. 2026
Valide jusqu'au
24 févr. 2030
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
Complété
Remplace
HX 1695779-1Système de management de la qualitéDélivré15 sept. 2025 → 24 févr. 2030
Périmètre de couverture
IVDR Classe B4IVDR Classe C2
6 périmètres
CLINICAL CHEMISTRY
IVR 0602 Devices intended to be used for screening, determination
or monitoring of physiological markers for a specific disease
W01010214 – GLYCOSYLATED/GLYCATED HAEMOGLOBIN
W01010502 – SPECIFIC CONTROLS (CLINICAL CHEMISTRY)
W01010503 – CALIBRATORS AND STANDARDS (CLINICAL
CHEMISTRY)
IVDR Classe C
CLINICAL CHEMISTRY
IVR 0608 Devices intended to be used for screening,
determination or monitoring of physiological markers
W01010108 - AMYLASE ISOENZYMES
W01010114 - CREATININE KINASE - MB ACTIVITY (CC)
W01010213 - GLUCOSE
W01010501 - ASSAYED MULTICOMPONENT CONTROLS (CC)
W01010502 - UNASSAYED MULTICOMPONENT CONTROLS (CC)
W01010503 - CALIBRATORS AND STANDARDS (CC)
IVDR Classe C
CLINICAL CHEMISTRY
IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
W01010103 ALANINE AMINO-TRANSFERASE
W01010105 ALKALINE PHOSPHATASE – TOTAL
W01010110 ASPARTATE AMINO-TRANSFERASE
W01010111 CHOLINESTERASE
W01010113 CREATINE KINASE – TOTAL
W01010116 GAMMA GLUTAMYLTRANSFERASE
W01010119 LACTATE DEHYDROGENASE L (LDH-L --> P )
W01010199 ENZYMES – OTHER
IVDR Classe B
IMMUNOCHEMISTRY (IMMUNOLOGY)
IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
W01020101 IMMUNOGLOBULINS (EXCEPT IGE)
W01020102 COMPLEMENT COMPONENTS
W01020103 TRANSPORT PROTEINS
W01020104 LIPOPROTEINS
W01020190 OTHER SPECIFIC PROTEINS
W01020701 ANEMIA
W01021110 RHEUMATOID FACTORS
W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
W01021520 CONTROLS - IMMUNOCHEMISTRY
W01021522 STANDARDS AND CALIBRATORS IMMUNOCHEMISTRY
IVDR Classe B
CLINICAL CHEMISTRY
IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
W01010201 ALBUMIN (CC)
W01010202 BILE ACIDS
W01010203 BILIRUBIN
W01010205 CHOLESTEROL
W01010207 CREATININE
W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL
W01010216 IRON (CC)
W01010230 TOTAL PROTEIN
W01010231 TRIGLYCERIDES
W01010232 URIC ACID
W01010299 SUBSTRATES - OTHER
IVDR Classe B
CLINICAL CHEMISTRY
IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
W01010303 CALCIUM
W01010306 MAGNESIUM
W01010307 PHOSPHATE INORGANIC / PHOSPHORUS
W01010501 MULTICOMPONENT CONTROLS (CLINICAL CHEMISTRY)
W01010503 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY)