EU Manufacturer
๐บ๐ธ United States
Active
Volcano Corporation
SRN: US-MF-000020094
ยท
Valley Centre Drive 3721, 92130 San Diego, United States
Basic UDI-DIs
30
Total Devices
30
On Market
30
Off Market
0
Certificates
7
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Valley Centre Drive 3721, 92130 San Diego, United States
- [email protected]
- Phone
- n/a
- Website
- n/a
Regulatory Overview
Regulation
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Eu Mdd
30
Classification
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Eu Md Class 3
21
Eu Md Class 2a
8
Eu Md Class 1
1
Device Types
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Certificate Health
Total
7
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
7
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | CE 742557 | BSI Group The Netherlands B.V. | Aug 15, 2022 | |||
| MDD Annex II Section 4 | CE 742147 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 742145 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 742150 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 742146 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 742149 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 735820 | BSI Group The Netherlands B.V. | May 26, 2024 |
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 | ||||
|---|---|---|---|---|
| CORE M2 Vascular System | EU MDD | Eu Md Class 2a | On Market | 1 |
| CORE Mobile System Medical Equipment | EU MDD | Eu Md Class 2a | On Market | 1 |
| CORE Series Precision Guided Therapy System | EU MDD | Eu Md Class 2a | On Market | 1 |
| ComboWire Pressure/Flow Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| ComboWire Pressure/Flow Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Eagle Eye Platinum RX Digital IVUS Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| Eagle Eye Platinum ST RX Digital IVUS Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| FloWire Doppler Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| FloWire Doppler Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| FloWire Doppler Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| OmniWire Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| OmniWire Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Pioneer Plus Catheter | EU MDD | Eu Md Class 2a | On Market | 1 |
| R-100 | EU MDD | Eu Md Class 1 | On Market | 1 |
| Reconnaissance PV .018 OTW Digital IVUS Catheter | EU MDD | Eu Md Class 2a | On Market | 1 |
| Refinity ST Rotational IVUS Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revolution 45MHz Rotational Imaging Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| SyncVision | EU MDD | Eu Md Class 2a | On Market | 1 |
| Verrata Plus Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Verrata Plus Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Verrata Plus Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Verrata Plus Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Verrata Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Verrata Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Verrata Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Verrata Pressure Guide Wire | EU MDD | Eu Md Class 3 | On Market | 1 |
| Visions PV .014P RX Digital IVUS Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| Visions PV .018 Digital IVUS Catheter | EU MDD | Eu Md Class 2a | On Market | 1 |
| Visions PV .035 Digital IVUS Catheter | EU MDD | Eu Md Class 3 | On Market | 1 |
| s5i | EU MDD | Eu Md Class 2a | On Market | 1 |