EU Manufacturer
๐บ๐ธ United States
Active
Penumbra, Inc.
SRN: US-MF-000008514
ยท
One Penumbra Place, 94502 Alameda, United States
Basic UDI-DIs
14
Total Devices
14
On Market
14
Off Market
0
Certificates
12
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- One Penumbra Place, 94502 Alameda, United States
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
12
Eu Mdr
2
Classification
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Eu Md Class 3
11
Eu Md Class 1
2
Eu Md Class 2a
1
Device Types
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Certificate Health
Total
12
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | 252.949 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.901 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.934 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.711 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.807 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.806 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.761 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.943 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.969 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.932 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 252.962 | National Standards Authority of Ireland (NSAI) | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | 252.885 | National Standards Authority of Ireland (NSAI) | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 4MAX DDC - Distal Delivery Catheter, 130 cm | EU MDD | Eu Md Class 3 | On Market | 1 |
| 6F Benchmark 95cm Straight | EU MDD | Eu Md Class 3 | On Market | 1 |
| Artemis Neuro Evacuation Device 1.5 mm | EU MDD | Eu Md Class 3 | On Market | 1 |
| Aspiration Catheter 3 | EU MDD | Eu Md Class 3 | On Market | 1 |
| Coil 400 Complex Standard, 7mm x 20 cm | EU MDD | Eu Md Class 3 | On Market | 1 |
| Neuron Delivery Catheter (115cm/12cm) | EU MDD | Eu Md Class 3 | On Market | 1 |
| POD, 3 mm x 20 cm | EU MDD | Eu Md Class 3 | On Market | 1 |
| PX SLIM 150 cm, 45ยฐ tip | EU MDD | Eu Md Class 3 | On Market | 1 |
| Penumbra ENGINE Canister โ Penumbra System | EU MDR | Eu Md Class 1 | On Market | 0 |
| Penumbra ENGINE Pump | EU MDD | Eu Md Class 2a | On Market | 1 |
| Penumbra Smart Coil Detachment Handle | EU MDR | Eu Md Class 1 | On Market | 0 |
| Penumbra Smart Coil Wave Extra Soft, 1 mm x 1 cm | EU MDD | Eu Md Class 3 | On Market | 1 |
| Reperfusion Catheter 3MAX, 153 cm | EU MDD | Eu Md Class 3 | On Market | 1 |
| Ruby Extra Soft, 2mm x 1 cm | EU MDD | Eu Md Class 3 | On Market | 1 |