This licence is the property of the Health Products & Food Branch Inspectorate and must be returned upon demand. Cette licence appartient au programme ...
Licence d'établissement pour les instruments médicaux
AXOGEN CORPORATION 13631 PROGRESS BOULEVARD SUITE 400 ALACHUA, FLORIDA UNITED STATES 32615 This licence is issued in accordance with the Medical Devices Regulations of the Food and Drugs Act for the following activities:
Cette licence est délivrée conformément à la Loi sur les aliments et drogues, règlement sur les instruments médicaux pour les activités qui suivent:
Distributor / Distributeur
Importer / Importateur
Manufacture Devices for Distribution / Fabricant d'instruments médicaux pour distribution
No / Non
No / Non
No / Non
No / Non No / Non
No / Non
Yes / Oui
No / Non
Class I / Classe I Class II / Classe II Class III / Classe III Class IV / Classe IV
No / Non
Attestation made :
Attestations faites :
The establishment has documented procedures in place in respect of: distribution records complaint handling recalls mandatory problem reporting handling, storage, delivery installation corrective action servicing
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[Y] [Y] [Y] [N] [Y] [N] [N] [N]
L'établissement a mis en oeuvre une procédure écrite concernant: les registres de distribution les plaintes les rappels rapports d'incident obligatoires la manutention, le stockage, la livraison l'installation, les mesures correctives l'entretien
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Issue Date, date de délivrance: 2013-09-25 Minister of Health Ministre de la santé
Countersigned: A/Director General, Health Products & Food Branch Inspectorate or delegated authority Contresigné par: Directeur Général intérimaire, Inspectorat de la Direction générale des produits de santé et des aliments ou autoritée déléguée
Don Boyer This licence is the property of the Health Products & Food Branch Inspectorate and must be returned upon demand. Cette licence appartient au programme d'Inspectorat de la Direction générale des produits de santé et des aliments et doit être retournée sur demande.
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Sites
AXOGEN CORPORATION 13631 PROGRESS BOULEVARD SUITE 400 ALACHUA, FLORIDA UNITED STATES 32615
Company ID 137217 No. d'identification de la société
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