130175
IV
Expired.
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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
Expired.
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Biotronik SE & Co. KG
Biotronik Ag
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
August 01, 2017
Expiry Date
June 27, 2018
Product Models
Entovis DR (371991), Entovis DR-T (371992), Entovis SR (371993), Entovis SR-T (371994), Entovis DR coated (372027), Entovis DR-T coated (372028), Entovis SR coated (372029), Entovis SR-T coated (372030)
ๆฉๆ็ปดๆฏDR (371991), ๆฉๆ็ปดๆฏDR-T (371992), ๆฉๆ็ปดๆฏSR (371993), ๆฉๆ็ปดๆฏSR-T (371994), ๆฉๆ็ปดๆฏDRๆถๅฑ (372027), ๆฉๆ็ปดๆฏDR-Tๆถๅฑ (372028), ๆฉๆ็ปดๆฏSRๆถๅฑ (372029), ๆฉๆ็ปดๆฏSR-Tๆถๅฑ (372030)