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Medical Device Division · registration 140266Active

Biotronik

Hong KongStent/Grafts, Vascular, CoronaryClass IVBiotronik AG
Official record identity
MDACS listing number
140266
Model name
PK Papyrus Covered Coronary Stent System (369380, 369381, 369382, 369383, 369384, 369385, 369386, 369387, 369388, 369389, 369390, 369391, 369392, 369393, 381789, 381790, 381791)
Registration date
April 02, 2026
Expiry date
August 11, 2029
Source update date
June 15, 2026
Status
Active
Official value: Valid
Classification
Risk class
Class IV
Official value: IV
Published category
Stent/Grafts, Vascular, Coronary
Published parties
Registrant / registration holder
Teleflex Medical Hong Kong Limited
Manufacturer
Biotronik AG
Official description

Stent/Grafts, Vascular, Coronary

Additional source fields
AMD nomenclature code
20452
Local responsible person phone
62916211
Published manufacturer address
Ackerstrasse 6, 8180 Bulach, Switzerland
Revision number
d
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.