Nom de l'organisation

SD Biosensor Inc.

SRN

KR-MF-000009168

Statut du fabricant

Actif

2 avertissements enregistrés — faire défiler le panneau pour tout voir.

• Biohazard During maintenance work, make sure to wear Latex gloves and overalls to prevent infection, and wear protective glasses when necessary. Do not throw away lint-free cloth for wiping at will. Please dispose of it properly in accordance with relevant regulations.

  AUTRE

• Warning Do not carry out maintenance work not explicitly stated in this chapter. Otherwise, it may cause system damage and personal injury. Do not touch components other than those that are clearly stated to be operated and maintained by users themselves. If the system is repaired without authorization, it may lead to system damage and personal injury, and make the terms promised in the maintenance contract no longer valid. After the maintenance work is completed, please confirm that the system works normally. Do not spill water, reagents, and other liquids on the mechanical or electrical parts of the system to prevent the water from entering the analyzer and thus damage it. If the analyzer is not going to be used in a long time (more than 1 weeks), or it needs to be carried, have it maintained by our customer service department or the local distributor to make sure it can still work normally in the next use. Do not perform maintenance during active testing or while the analyzer is running, as this may lead to inaccurate results, system damage, serious personal injury. For all operations that require the analyzer to be powered off, take care to disconnect it from the power supply to avoid personal injury. Keep the work area clean during inspection and maintenance.

  AUTRE

Marché principal en Italie ; disponible dans 23 pays au total.

Dénomination commerciale

STANDARD™ i2000

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

08800111720260

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

88001117IPAA01IA02V8

Numéro de référence/catalogue

16IA200

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque RDIV

Les classes de risque du RDIV classent les dispositifs de diagnostic in vitro du risque le plus faible (classe A) au plus élevé (classe D), selon le risque pour le patient et la santé publique d'un résultat erroné.

IVDR Classe A

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

STANDARDTM i2000 is an in vitro diagnostic device that is intended for qualitative or quantitative testing of analytes in human serum, whole blood, urine and cerebrospinal fluid samples, including vitamins detection, amino acids and blood drug concentration detection, hormones detection, myocardial disease detection, infectious disease detection, auto-antibody detection, tumor-related antigens detection, proteins and polypeptides detection, kidney disease and liver disease detection, and immune function detection. The STANDARD™ i2000 Analyzer consists of two units: control unit, analytical unit. ULTRA i2000 is an in vitro diagnostic device that is intended for qualitative or quantitative testing of analytes in human serum, whole blood, urine and cerebrospinal fluid samples, including vitamins detection, amino acids and blood drug concentration detection, hormones detection, myocardial disease detection, infectious disease detection, auto-antibody detection, tumor-related antigens detection, proteins and polypeptides detection, kidney disease and liver disease detection, and immune function detection. The ULTRA i2000 Analyzer consists of two units: control unit, analytical unit.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0201020102AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

• Dispositifs médicaux de IVDR Classe A dans EUDAMED

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.

Santé des certificats sur le portefeuille de ce fabricant.