Medical Device Division · registration 240112ActiveBiotronik
Hong KongCatheters, Vascular, Angioplasty, Balloon, Peripheral ArteryClass IIBiotronik AG
Official record identity
- MDACS listing number
- 240112
- Model name
- Oscar (454332, 454333, 454334, 454335, 454336, 454337, 454338, 454339, 454340, 454341, 454342, 454343, 454344, 454345, 454346, 454347, 454348, 454349, 454350, 454351, 454352, 454353)
- Registration date
- April 02, 2026
- Expiry date
- April 02, 2029
- Source update date
- June 15, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
- Published category
- Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
Official value: II
Published parties
- Registrant / registration holder
- Teleflex Medical Hong Kong Limited
- Manufacturer
- Biotronik AG
Official description
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
Additional source fields
- AMD nomenclature code
- 34317
- Local responsible person phone
- 62916211
- Published manufacturer address
- Ackerstrasse 6, 8180 Bülach, Switzerland
- Revision number
- b
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.