Medical Device Division · registration 240256ActiveAcandis
Hong KongCatheters, Vascular, Angioplasty, Balloon, Intracranial ArteryClass IVAcandis GmbH
Official record identity
- MDACS listing number
- 240256
- Model name
- NeuroSpeed PTA Balloon Catheter ST (01-000620, 01-000621, 01-000622, 01-000623, 01-000624, 01-000630, 01-000631, 01-000632, 01-000633, 01-000634), NeuroSpeed PTA Balloon Catheter (01-000600, 01-000601, 01-000602, 01-000603, 01-000604, 01-000605, 01-000610, 01-000611, 01-000612, 01-000613, 01-000614, 01-000615)
- Registration date
- March 11, 2026
- Expiry date
- July 10, 2029
- Source update date
- March 18, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Catheters, Vascular, Angioplasty, Balloon, Intracranial Artery
Official value: IV
Published parties
- Registrant / registration holder
- Synapse Therapeutics Limited
- Manufacturer
- Acandis GmbH
Official description
Catheters, Vascular, Angioplasty, Balloon, Intracranial Artery
Additional source fields
- AMD nomenclature code
- 32030
- Traditional Chinese local responsible person
- 百谷醫療科技有限公司
- Local responsible person phone
- 31881638
- Published manufacturer address
- Theodor-Fahrner-Strasse 6, 75177 Pforzheim, Germany
- Revision number
- a
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.