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Medical Device Division · registration 230032Active

Jotec

Hong KongStent/Grafts, Vascular, AorticClass IVJOTEC GmbH
Official record identity
MDACS listing number
230032
Model name
E-nya Thoracic Stent Graft System (90SO2222S09-00, 90SO2222S13-00, 90SO2222S17-00, 90SO2525S09-00, 90SO2525S13-00, 90SO2525S17-00, 90SO2828S09-00, 90SO2828S13-00, 90SO2828S17-00, 90SO3131S09-00, 90SO3131S13-00, 90SO3131S17-00, 90SO3131S23-00, 90SO3434S09-00, 90SO3434S13-00, 90SO3434S17-00, 90SO3434S23-00, 90SO3737S09-00, 90SO3737S13-00, 90SO3737S17-00, 90SO3737S23-00, 90SO4040S09-00, 90SO4040S13-00, 90SO4040S17-00, 90SO4040S23-00, 90SO4343S09-00, 90SO4343S13-00, 90SO4343S17-00, 90SO4343S23-00, 90SO4646S09-00, 90SO4646S13-00, 90SO4646S17-00, 90SO4646S23-00, 90SO2522S13-00, 90SO2825S13-00, 90SO2822S17-00, 90SO3128S13-00, 90SO3125S17-00, 90SO3122S23-00, 90SO3431S13-00, 90SO3428S17-00, 90SO3425S23-00, 90SO3734S13-00, 90SO3731S17-00, 90SO3728S23-00, 90SO4037S13-00, 90SO4034S17-00, 90SO4031S23-00, 90SO4340S13-00, 90SO4337S17-00, 90SO4334S23-00, 90SO4643S13-00, 90SO4640S17-00, 90SO4637S23-00, 90TC2222S09-00, 90TC2222S17-00, 90TC2525S09-00, 90TC2525S17-00, 90TC2828S09-00, 90TC2828S17-00, 90TC3131S09-00, 90TC3131S17-00, 90TC3131S23-00, 90TC3434S09-00, 90TC3434S17-00, 90TC3434S23-00, 90TC3737S09-00, 90TC3737S17-00, 90TC3737S23-00, 90TC4040S09-00, 90TC4040S17-00, 90TC4040S23-00, 90TC4343S09-00, 90TC4343S17-00, 90TC4343S23-00, 90TC4646S09-00, 90TC4646S17-00, 90TC4646S23-00, 90TC2522S13-00, 90TC2825S13-00, 90TC2822S17-00, 90TC3128S13-00, 90TC3125S17-00, 90TC3122S17-00, 90TC3431S13-00, 90TC3428S17-00, 90TC3425S17-00, 90TC3734S13-00, 90TC3731S17-00, 90TC3728S17-00, 90TC4037S13-00, 90TC4034S17-00, 90TC4031S17-00, 90TC4340S13-00, 90TC4337S17-00, 90TC4334S17-00, 90TC4643S13-00, 90TC4640S17-00, 90TC4637S17-00)
Registration date
February 08, 2023
Expiry date
February 08, 2028
Source update date
July 22, 2025
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Stent/Grafts, Vascular, Aortic
Published parties
Registrant / registration holder
Pacific Medical (Hong Kong) Company Limited
Manufacturer
JOTEC GmbH
Official description

Stent/Grafts, Vascular, Aortic

Additional source fields
AMD nomenclature code
20453
Local responsible person phone
23438009
Published manufacturer address
Lotzenäcker 23, 72379 Hechingen, Germany
About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.