Medical Device Division · registration 230148ActiveAcandis GmbH
Hong KongStents, Vascular, Intracranial Artery, Drug-ElutingClass IVAcandis GmbH
Official record identity
- MDACS listing number
- 230148
- Model name
- DERIVO 2 heal Embolisation Device (01-104001, 01-104002, 01-104003, 01-104004, 01-104005, 01-104006, 01-104007, 01-104008, 01-104009, 01-104010, 01-104011, 01-104012, 01-104013 , 01-104014 , 01-104015 , 01-104016 , 01-104017 , 01-104018 , 01-104019 , 01-104020 , 01-104021 , 01-104022 , 01-104023 , 01-104024 , 01-104025 , 01-104026 , 01-104027 , 01-104028 , 01-104029 , 01-104030 , 01-104031 , 01-104032 , 01-104033 , 01-104034, 01-104035, 01-104036, 01-104037, 01-104038, 01-104039, 01-104040, 01-104041, 01-104042, 01-104043, 01-104044, 01-104045, 01-104046, 01-104047, 01-104048, 01-104049, 01-104050, 01-104051, 01-104052, 01-104053, 01-104054, 01-104055, 01-104056, 01-104057, 01-104058, 01-104059 , 01-104060 , 01-104061 , 01-104062 , 01-104063 , 01-104064 , 01-104065, 01-104066, 01-104067, 01-104068, 01-104069, 01-104070, 01-104071, 01-104072, 01-104073, 01-104074)
- Registration date
- September 02, 2024
- Expiry date
- April 27, 2028
- Source update date
- March 10, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Synapse Therapeutics Limited
- Manufacturer
- Acandis GmbH
Official description
Stents, Vascular, Intracranial Artery
Additional source fields
- AMD nomenclature code
- 28243
- 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.