Medical Device Division · registration 100494ExpiredPenumbra
Hong KongCatheters, Vascular, Embolectomy/ThrombectomyClass IVPenumbra, Inc.
Official record identity
- MDACS listing number
- 100494
- Model name
- Penumbra System (PSC026, PSC032, PSC041, PSC054, 3MAXC, 5MAXACE064, PSS026, PSS032, PSS041, PSS054, PST1, PST2, PSF026, PSF032, PSF041, PSF054)
- Registration date
- January 18, 2016
- Expiry date
- January 18, 2021
- Source update date
- December 17, 2019
- 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, Embolectomy/Thrombectomy
Additional source fields
- AMD nomenclature code
- 10714
- 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.