Medical Device Division · registration 100495ExpiredPenumbra
Hong KongCatheters, Vascular, GuidingClass IVPenumbra, Inc.
Official record identity
- MDACS listing number
- 100495
- Model name
- Neuron Intracranial Access System (PND6F070956, PND6F070956M, PND6F0701058, PND6F0701058M, PND6F10512, PND6F10512M, PND6F1056, PND6F1056M, PND6F11512, PND6F11512M, PND6F1156, PND6F1156M, PNS5F120H1, PNS5F120SIM, PNS5F120BER, PNS5F130H1, PNS5F130SIM, PNS5F130BER, PNML6F088704M, PNML6F088704, PNML6F088804M, PNML6F088804, PNML6F088904M, PNML6F088904, PNML6F0881004M, PNML6F0881004, PNML6F088704MR, PNML6F088704R, PNML6F088804MR, PNML6F088804R, PNML6F088904MR, PNML6F088904R, PNML6F0881004MR, PNML6F0881004R, PNMD8F088704M, PNMD8F088704, PNMD8F088804M, PNMD8F088804, PNMD8F088904M, PNMD8F088904, PNMD8F0881004M, PNMD8F0881004, PNS6F125SIM, PNS6F125H1, PNS6F125BER, PNS6F125SIMV, PNS6F105SIM, PNS6F105H1, PNS6F105BER, PNS6F105SIMV)
- Registration date
- January 18, 2016
- Expiry date
- January 18, 2021
- Source update date
- May 31, 2016
- Status
- Expired
Classification
- Risk class
- Class IV
Official value: IV
Published parties
- Registrant / registration holder
- Synapse Therapeutics Limited
- Manufacturer
- Penumbra, Inc.
Official description
Catheters, Vascular, Guiding
Additional source fields
- AMD nomenclature code
- 17846
- Traditional Chinese local responsible person
- 百谷醫療科技有限公司
- Local responsible person phone
- 31881638
- Published manufacturer address
- One Penumbra Place, Alameda, CA 94502, USA
- Published remarks
- Expired.
- 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.