Medical Device Division · registration 180039ActiveBiotronik
Hong KongCatheters, Vascular, Angioplasty, Balloon, Peripheral ArteryClass IIBiotronik AG
Official record identity
- MDACS listing number
- 180039
- Model name
- PASSEO-18 Peripheral Dilatation Catheter (366098, 357451, 357452, 357453, 357454, 357455, 357456, 357457, 366099, 357458, 357459, 357460, 357461, 357462, 357463, 357464, 366100, 366101, 366102, 366103, 357465, 357466, 357467, 357468, 366104, 357469, 357470, 357471, 357472, 357473, 357474, 357475, 366105, 357476, 357477, 357478, 357479, 357480, 357481, 357482, 366106, 366107, 366108, 366109, 366110, 366111, 366112, 366113, 366114, 357483, 357484, 357485, 376272, 376273, 376274, 376275, 376276, 376277, 376278, 376279, 376280, 376281, 376282, 376283, 357486, 357487, 357488, 357489, 357490, 366116, 366117, 357491, 357492, 357493, 357494, 357495, 357496, 357497, 366120, 366121, 366122, 357498, 357499, 357500, 357501, 357502, 357503, 357504, 357505, 357506, 366124, 366125, 357507, 357508, 357509, 357510, 357511, 366127, 366128, 366130, 366131, 366132, 366133, 366134, 366135, 366136, 357512, 357513, 357514, 376292, 376293, 376294, 376295, 376297, 376298, 376299, 376300, 376301, 376302, 376303, 366115, 366118, 366119, 366123, 366126, 366129, 366137, 376296)
- Registration date
- April 02, 2026
- Expiry date
- February 20, 2028
- 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 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.