Medical Device Division · registration 150146Expired

Penumbra

Name: Penumbra — Medical Device Division 150146
Creator: Penumbra, Inc.
Keywords: Penumbra, Penumbra, 150146, Occluders, Vascular, Intravascular Embolization, Coil, Medical Device Division

Hong KongOccluders, Vascular, Intravascular Embolization, CoilClass IVPenumbra, Inc.

Verified

Official record identity

MDACS listing number: 150146
Model name: POD System (RBYPOD4S1 to RBYPOD4S19, RBYPOD4S, RBYPOD4S21 to RBYPOD4S60, RBYPOD4HS1 to RBYPOD4HS60, RBYPOD5S1 to RBYPOD5S19, RBYPOD5S, RBYPOD5S21 to RBYPOD5S60, RBYPOD5HS1 to RBYPOD5HS60, RBYPOD6S1 to RBYPOD6S34, RBYPOD6S, RBYPOD6S36 to RBYPOD6S60, RBYPOD6HS1 to RBYPOD6HS60, RBYPOD7S1 to RBYPOD7S60, RBYPOD7HS1 to RBYPOD7HS60, RBYPOD8S1 to RBYPOD8S39, RBYPOD8S, RBYPOD8S41 to RBYPOD8S60, RBYPOD41 to RBYPOD429, RBYPOD4, RBYPOD431 to RBYPOD460, RBYPOD4H1 to RBYPOD4H60, RBYPOD51 to RBYPOD529, RBYPOD5, RBYPOD531 to RBYPOD560, RBYPOD5H1 to RBYPOD5H60, RBYPOD61 to RBYPOD649, RBYPOD6, RBYPOD651 to RBYPOD660, RBYPOD6H1 to RBYPOD6H60, RBYPOD71 to RBYPOD760, RBYPOD7H1 to RBYPOD7H60, RBYPOD81 to RBYPOD859, RBYPOD8, RBYPOD4L1 to RBYPOD4L34, RBYPOD4L, RBYPOD4L36 to RBYPOD4L60, RBYPOD4HL1 to RBYPOD4HL60, RBYPOD5L1 to RBYPOD5L39, RBYPOD5L, RBYPOD5L41 to RBYPOD5L60, RBYPOD5HL1 to RBYPOD5HL60, RBYPOD6L1 to RBYPOD6L60, RBYPOD6HL1 to RBYPOD6HL60, RBYPOD7L1 to RBYPOD7L60, RBYPOD7HL1 to RBYPOD7HL60, RBYPOD8L1 to RBYPOD8L60, 400POD4S1 to 400POD4S19, 400POD4S, 400POD4S21 to 400POD4S60, 400POD4HS1 to 400POD4HS60, 400POD5S1 to 400POD5S19, 400POD5S, 400POD5S21 to 400POD5S60, 400POD5HS1 to 400POD5HS60, 400POD6S1 to 400POD6S34, 400POD6S, 400POD6S36 to 400POD6S60, 400POD6HS1 to 400POD6HS60, 400POD7S1 to 400POD7S60, 400POD7HS1 to 400POD7HS60, 400POD8S1 to 400POD8S39, 400POD8S, 400POD8S41 to 400POD8S60, 400POD41 to 400POD429, 400POD4, 400POD431 to 400POD460, 400POD4H1 to 400POD4H60, 400POD51 to 400POD529, 400POD5, 400POD531 to 400POD560, 400POD5H1 to 400POD5H60, 400POD61 to 400POD649, 400POD6, 400POD651 to 400POD660, 400POD6H1 to 400POD6H60, 400POD71 to 400POD760, 400POD7H1 to 400POD7H60, 400POD81 to 400POD859, 400POD8, 400POD4L1 to 400POD4L34, 400POD4L, 400POD4L36 to 400POD4L60, 400POD4HL1 to 400POD4HL60, 400POD5L1 to 400POD5L39, 400POD5L, 400POD5L41 to 400POD5L60, 400POD5HL1 to 400POD5HL60, 400POD6L1 to 400POD6L60, 400POD6HL1 to 400POD6HL60, 400POD7L1 to 400POD7L60, 400POD7HL1 to 400POD7HL60, 400POD8L1 to 400POD8L60)
Registration date: July 02, 2020
Expiry date: July 02, 2025
Source update date: July 06, 2023
Status: Expired

Classification

Risk class: Class IV
Published category: Occluders, Vascular, Intravascular Embolization, Coil

Published parties

Registrant / registration holder: Synapse Therapeutics Limited
Manufacturer: Penumbra, Inc.

Official description

Occluders, Vascular, Intravascular Embolization, Coil

Additional source fields

AMD nomenclature code: 22543
Traditional Chinese local responsible person: 百谷醫療科技有限公司
Local responsible person phone: 31881638
Published manufacturer address: 1351 Harbor Bay Parkway, Alameda, CA 94502, USA
Published remarks: Expired.
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.