Authorized Representative
🇳🇱 Netherlands
Active
ACIST Europe BV
SRN: NL-AR-000002151
·
Argonstraat 3, 6422PH Heerlen, Netherlands
Manufacturers
4
Devices
14
Certificates
2
PRRCs
1
Basic Information
- Address
- Argonstraat 3, 6422PH Heerlen, Netherlands
- [email protected]
- Phone
- +31652632299
- Website
- www.ACIST.com
- VAT Number
- NL808081196B01
- Trade Register
- 30159397
- EORI
- NL808081196
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| BRACCO SUISSE SA | 🇨🇭 Switzerland | CH-MF-000022733 |
| ACIST Medical Systems, Inc. | 🇺🇸 United States | US-MF-000010784 |
| E-Z-EM, Inc. A subsidiary of Bracco Diagnostics Inc. a.d.b.a. Bracco Diagnostics Inc. | 🇺🇸 United States | US-MF-000008497 |
| Bracco Injeneering SA | 🇨🇭 Switzerland | CH-MF-000019387 |
Manufacturers
E-Z-EM, Inc. A subsidiary of Bracco Diagnostics Inc. a.d.b.a. Bracco Diagnostics Inc.
Manufacturer
🇺🇸 United States·1 Importer
ACIST Medical Systems, Inc.
Manufacturer
🇺🇸 United States·2 Basic UDI-DIs·7 Devices·2 Importers
Bracco Injeneering SA
Manufacturer
🇨🇭 Switzerland·6 Basic UDI-DIs·6 Devices·1 Importer·BSI Group The Netherlands B.V.
BRACCO SUISSE SA
Manufacturer
🇨🇭 Switzerland·1 Basic UDI-DI·1 Device·1 Importer·BSI Group The Netherlands B.V.
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 598543 | Bracco Injeneering SA | BSI Group The Netherlands B.V. | Expired |
| MDD Annex II (excluding section 4) | CE 619401 | BRACCO SUISSE SA | BSI Group The Netherlands B.V. | Expired |
Devices
ACIST CVi AngioTouch® AT X65 HAND CONTROLLER KIT
Device
EU MDR
·
Eu Md Class 2a
·ACIST Medical Systems, Inc.·On the market·32 countries
ACIST CVi AngioTouch® AT P65 HAND CONTROLLER KIT
Device
EU MDR
·
Eu Md Class 2a
·ACIST Medical Systems, Inc.·On the market·32 countries
ACIST CVi AngioTouch® AT P54 HAND CONTROLLER KIT
Device
EU MDR
·
Eu Md Class 2a
·ACIST Medical Systems, Inc.·On the market·32 countries
ACIST CVi BT2000 MANIFOLD KIT
Device
EU MDR
·
Eu Md Class 2a
·ACIST Medical Systems, Inc.·On the market·32 countries
ACIST CVi A2000V SYRINGE KIT
Device
EU MDR
·
Eu Md Class 2a
·ACIST Medical Systems, Inc.·On the market·32 countries
ACIST CVi A2000
Device
EU MDR
·
Eu Md Class 2a
·ACIST Medical Systems, Inc.·On the market·32 countries
NEXO
Device
EU MDR
·
Eu Md Class 1
·ACIST Medical Systems, Inc.·On the market·14 countries
CT Expres Patient Line
Device
EU MDD
·
Eu Md Class 2a
·Bracco Injeneering SA·On the market·18 countries
CT Expres Multi Patient Set
Device
EU MDD
·
Eu Md Class 2a
·Bracco Injeneering SA·On the market·18 countries
CT Expres 4D
Device
EU MDD
·
Eu Md Class 2b
·Bracco Injeneering SA·On the market·18 countries
EmpowerCTA+ Injector System
Device
EU MDD
·
Eu Md Class 2b
·Bracco Injeneering SA·On the market·26 countries
CT Expres Patient Set Evo
Device
EU MDD
·
Eu Md Class 2a
·Bracco Injeneering SA·On the market·19 countries
CT Expres Evo
Device
EU MDD
·
Eu Md Class 2b
·Bracco Injeneering SA·On the market·19 countries
VueBox®
Device
EU MDD
·
Eu Md Class 2a
·BRACCO SUISSE SA·On the market·21 countries