Medical Device Division · registration 200330ActivePenumbra
Hong KongCatheters, Vascular, Embolectomy/ThrombectomyClass IVPenumbra, Inc.
Official record identity
- MDACS listing number
- 200330
- Model name
- Penumbra System - Reperfusion Catheter 3MAX 160 cm (3MAXC), Reperfusion Catheter RED 43 (RED43136, RED43138, RED43160, RED43, RED43167, RED43KIT136, RED43KIT138, RED43KIT160, RED43KIT, RED43KIT167), Reperfusion Catheter RED 62 (RED62132, RED62S, RED62L, RED62KIT132, RED62SKIT, RED62LKIT), Reperfusion Catheter RED 68, 132 cm (RED68, RED68KIT), Reperfusion Catheter RED 72, 132 cm (RED72, RED72KIT), Reperfusion Catheter RED 72 SeNDit Technology (RED72SDKIT, RED72SDKIT127, RED72SDKIT125, RED72SDKIT120, RED72SDKIT115), Aspiration Tubing (PRT)
- Registration date
- September 05, 2025
- Expiry date
- October 14, 2030
- Source update date
- September 17, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Asia Actual Limited
- Manufacturer
- Penumbra, Inc.
Official description
Catheters, Vascular, Embolectomy/Thrombectomy
Additional source fields
- AMD nomenclature code
- 10714
- Local responsible person phone
- 28933118
- Published manufacturer address
- One Penumbra Place, Alameda, CA 94502, USA
- 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.