Zhejiang Orient Gene Biotech Co., Ltd

SRN

CN-MF-000017965

Rôle

Fabricant

Pays

Chine

Nom de l'organisation

Zhejiang Orient Gene Biotech Co., Ltd

Numéro TVA UE

Non applicable

Registre du commerce

913305007804719612

Date d'enregistrement

13 déc. 2021

Email

joyce.pang@orientgene.com

Adresse

3787#, EAST YANGGUANG AVENUE, DIPU STREET, ANJI 313300 313300 HUZHOU,ZHEJIANG CHINE

Nom

Agencia Española de Medicamentos y Productos Sanitarios

SRN

ES-CA-010

Téléphone

+34 (91) 822 5274

Email

sgps@aemps.es

• MIAO July
  the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released, Sign batch product release approval.
  Masqué
• YANG Young
  1. the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. 2. For devices conducting clinical trials, the statement referred to in Section 4.1 of Annex XIV is issued. That is, "in addition to the aspects covered in clinical trials, the device meets general safety and performance requirements and precautions have been taken to protect the health and safety of users".
  Masqué
• PANG Joyce
  1) comply with the marketing surveillance obligation under Article 10(9) to make sure that the device manufacturer shall implement and maintain an up-to-date PMS system in accordance with Article 78, sign and approve the PMS plan, the PMS report and the PSUR.2) fulfillment of reporting obligations under Articles 82 to 86 of the vigilance system, including reporting and analysis of serious accidents and FSCA, trend reporting and implementing acts. 3)sign the EU DOC and keep it up-to-date.
  Masqué

Aucun certificat enregistré pour ce fabricant.

Aucun document enregistré pour cette entreprise pour le moment.