Taiwan FDA registration c28cc1389398e2738184a96e73a57a19
“Penumbra” INDIGO Aspiration System CAT RX
TW: “彼娜波” 英迪高抽吸系統
Taiwan·Risk Class 2·MD·Penumbra, Inc.·Registered Nov 01, 2021 – Nov 01, 2026ActiveRegistration details
- Analysis ID
- c28cc1389398e2738184a96e73a57a19
- License Form
- Ministry of Health Medical Device Import No. 035014
- Customs Code
- DHA05603501407
Company information
- Manufacturer
- Penumbra, Inc.
- Manufacturer Country
- United States
- Authorized Representative
- FRONTIER BIO-MEDICAL INC.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E5150 Thrombectomy catheter
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 01, 2021
- Expiry Date
- Nov 01, 2026
About this record
Access comprehensive regulatory information for “Penumbra” INDIGO Aspiration System CAT RX in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number c28cc1389398e2738184a96e73a57a19 and manufactured by Penumbra, Inc.. The authorized representative in Taiwan is FRONTIER BIO-MEDICAL INC..
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