Medical Device Division · registration 160416ExpiredBiosensors
Hong KongCatheters, Vascular, Angioplasty, BalloonClass IVBiosensors Europe SA
Official record identity
- MDACS listing number
- 160416
- Model name
- BioPath Paclitaxel Eluting PTA Balloon Catheter (OTW) (BPTH-14-2040 L, BPTH-14-2040 XL, BPTH-14-2080 L, BPTH-14-2080 XL, BPTH-14-20120 L, BPTH-14-20120 XL, BPTH-14-20150 L, BPTH-14-20150 XL, BPTH-14-2540 L, BPTH-14-2540 XL, BPTH-14-2580 L, BPTH-14-2580 XL, BPTH-14-25120 L, BPTH-14-25120 XL, BPTH-14-25150 L, BPTH-14-25150 XL, BPTH-14-3040 L, BPTH-14-3040 XL, BPTH-14-3080 L, BPTH-14-3080 XL, BPTH-14-30120 L, BPTH-14-30120 XL, BPTH-14-30150 L, BPTH-14-30150 XL, BPTH-14-3540 L, BPTH-14-3540 XL, BPTH-14-3580 L, BPTH-14-3580 XL, BPTH-14-35120 L, BPTH-14-35120 XL, BPTH-14-35150 L, BPTH-14-35150 XL, BPTH-14-4040 L, BPTH-14-4040 XL, BPTH-14-4080 L, BPTH-14-4080 XL, BPTH-35-4020 S, BPTH-35-4020 L, BPTH-35-4040 S, BPTH-35-4040 L, BPTH-35-4060 S, BPTH-35-4060 L, BPTH-35-4080 S, BPTH-35-4080 L, BPTH-35-40100 S, BPTH-35-40100 L, BPTH-35-40120 S, BPTH-35-40120 L, BPTH-35-40150 S, BPTH-35-40150 L, BPTH-35-5020 S, BPTH-35-5020 L, BPTH-35-5040 S, BPTH-35-5040 L, BPTH-35-5060 S, BPTH-35-5060 L, BPTH-35-5080 S, BPTH-35-5080 L, BPTH-35-50100 S, BPTH-35-50100 L, BPTH-35-50120 S, BPTH-35-50120 L, BPTH-35-50150 S, BPTH-35-50150 L, BPTH-35-6020 S, BPTH-35-6020 L, BPTH-35-6040 S, BPTH-35-6040 L, BPTH-35-6060 S, BPTH-35-6060 L, BPTH-35-6080 S, BPTH-35-6080 L, BPTH-35-60100 S, BPTH-35-60100 L, BPTH-35-60120 S, BPTH-35-60120 L, BPTH-35-60150 S, BPTH-35-60150 L, BPTH-35-7020 S, BPTH-35-7020 L, BPTH-35-7040 S, BPTH-35-7040 L, BPTH-35-7060 S, BPTH-35-7060 L, BPTH-35-7080 S, BPTH-35-7080 L, BPTH-35-70100 S, BPTH-35-70100 L, BPTH-35-70120 S, BPTH-35-70120 L, BPTH-35-70150 S, BPTH-35-70150 L, BPTH-35-8020 S, BPTH-35-8020 L, BPTH-35-8040 S, BPTH-35-8040 L, BPTH-35-8060 S, BPTH-35-8060 L, BPTH-35-8080 S, BPTH-35-8080 L, BPTH-35-80100 S, BPTH-35-80100 L )
- Registration date
- December 05, 2016
- Expiry date
- December 05, 2021
- Source update date
- October 10, 2024
- Status
- Expired
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Pacific Medical (Hong Kong) Company Limited
- Manufacturer
- Biosensors Europe SA
Official description
Catheters, Vascular, Angioplasty, Balloon
Additional source fields
- AMD nomenclature code
- 17184
- Local responsible person phone
- 23438009
- Published manufacturer address
- Rue de Lausanne 29, 1110 Morges, Switzerland
- Published remarks
- Expired.
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.