EU Manufacturer
๐บ๐ธ United States
Active
ACIST Medical Systems, Inc.
SRN: US-MF-000010784
ยท
Fuller Road 7905, 55344 Eden Prairie, United States
Basic UDI-DIs
2
Total Devices
7
On Market
7
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Fuller Road 7905, 55344 Eden Prairie, United States
- [email protected]
- Phone
- +1 612-394-6382
- Website
- https://acist.com/
Regulatory Overview
Regulation
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Eu Mdr
2
Classification
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Eu Md Class 1
1
Eu Md Class 2a
1
Device Types
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Certificate Health
No certificates registered for this manufacturer.
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 | ||||
|---|---|---|---|---|
| ACIST CVi A2000 | EU MDR | Eu Md Class 2a | On Market | 0 |
| ACIST CVi A2000V SYRINGE KIT | EU MDR | Eu Md Class 2a | On Market | 0 |
| ACIST CVi AngioTouchยฎ AT P54 HAND CONTROLLER KIT | EU MDR | Eu Md Class 2a | On Market | 0 |
| ACIST CVi AngioTouchยฎ AT P65 HAND CONTROLLER KIT | EU MDR | Eu Md Class 2a | On Market | 0 |
| ACIST CVi AngioTouchยฎ AT X65 HAND CONTROLLER KIT | EU MDR | Eu Md Class 2a | On Market | 0 |
| ACIST CVi BT2000 MANIFOLD KIT | EU MDR | Eu Md Class 2a | On Market | 0 |
| NEXO | EU MDR | Eu Md Class 1 | On Market | 0 |