Medical Device Division · registration 230442ActivePenumbra
Hong KongCatheters, Vascular, GuidingClass IVPenumbra, Inc.
Official record identity
- MDACS listing number
- 230442
- Model name
- NEURON Intracranial Access System (PND6F070956, PND6F0701058, PND6F070956M, PND6F0701058M, PND6F11512, PND6F11512M, PND6F1156, PND6F1156M, PND6F10512, PND6F10512M, PND6F1056, PND6F1056M), NEURON MAX System (PNML6F088804M, PNML6F088904M, PNML6F088704M, PNML6F088704, PNML6F088804, PNML6F088904, PNML6F0881004M, PNML6F0881004, PNML6F088704MR, PNML6F088704R, PNML6F088804MR, PNML6F088804R, PNML6F088904MR, PNML6F088904R, PNML6F0881004MR, PNML6F0881004R, PNS6F125SIM, PNS6F125H1, PNS6F125BER, PNS6F125SIMV, PNS6F105SIM, PNS6F105H1, PNS6F105BER, PNS6F105SIMV), Benchmark Intracranial Access System (BMK6F95M, BMK6F105M, BMK6F115M), Benchmark BMX96 Access System (BMX9680, BMX9690, BMX96100, BMX9680BER105, BMX9690BER125, BMX9690SIM125, BMX9690SIMV125, BMX96100BER125, BMX96100H1125, BMX96100SIM125, BMX96100SIMV125)
- Registration date
- May 28, 2026
- Expiry date
- November 27, 2028
- Source update date
- May 29, 2026
- 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, Guiding
Additional source fields
- AMD nomenclature code
- 17846
- Local responsible person phone
- 28933118
- Published manufacturer address
- One Penumbra Place, Alameda, CA 94502, USA
- Revision number
- b
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.