160492
IV
current
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This profile provides complete Hong Kong MDACS registration information for Pacemakers, Cardiac, Implantable. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Pacemakers, Cardiac, Implantable
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
12913
Product Code Detail
12913 Pacemakers, Cardiac, Implantable
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
BIOTRONIK SE & Co. KG
Biotronik Ag
Germany
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Woermannkehre 1, 12359 Berlin, Germany
Woermannkehre 1, 12359 ๆๆ, ๅพทๅฝ
Authorised Representative (AR)
Biotronik Hong Kong Limited
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ฌๅธ
31904500
Regulatory Timeline
Registration Date
December 10, 2021
Expiry Date
January 06, 2027
Product Models
Edora 8 DR-T (407145), Edora 8 SR-T (407157), Edora 8 DR (407152), Edora 8 SR (407164)
Edora 8 DR-T (407145), Edora 8 SR-T (407157), Edora 8 DR (407152), Edora 8 SR (407164)