Authorized Representative
π©πͺ Germany
Active
Veranex Germany GmbH
SRN: DE-AR-000005578
Β·
Landsberger Str. 302, 80687 Munich, Germany
Manufacturers
20
Devices
32
Certificates
1
PRRCs
1
Basic Information
- Address
- Landsberger Str. 302, 80687 Munich, Germany
- [email protected]
- Website
- www.veranex.com
- VAT Number
- DE316200164
- Trade Register
- Handelsregister Freiburg
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Asecud SA | π¨π Switzerland | CH-MF-000024693 |
| Lobeck Medical AG | π¨π Switzerland | CH-MF-000029449 |
| Lucid Diagnostics | πΊπΈ United States | US-MF-000020362 |
| Smartcanula LLC | π¨π Switzerland | CH-MF-000020902 |
| Aleva Neurotherapeutics SA | π¨π Switzerland | CH-MF-000015804 |
| SurgiBox Inc. | πΊπΈ United States | US-MF-000047332 |
| Fabrinal SA | π¨π Switzerland | CH-MF-000015863 |
| Aktiia SA | π¨π Switzerland | CH-MF-000015833 |
| Diagramma AG | π¨π Switzerland | CH-MF-000015852 |
| Abionic SA | π¨π Switzerland | CH-MF-000026307 |
| Rheon Medical SA | π¨π Switzerland | CH-MF-000015835 |
| Luciole Medical AG | π¨π Switzerland | CH-MF-000015856 |
| Gondola Medical Technologies SA | π¨π Switzerland | CH-MF-000015837 |
| veldana medical S.A. | π¨π Switzerland | CH-MF-000015832 |
| Resistell AG | π¨π Switzerland | CH-MF-000039090 |
| Microba Pty Ltd | π¦πΊ Australia | AU-MF-000024781 |
| Lambda Health System SA | π¨π Switzerland | CH-MF-000016302 |
| docjo GmbH | π¨π Switzerland | CH-MF-000018889 |
| Phagenesis Ltd | π¬π§ United Kingdom | GB-MF-000015848 |
| Vektor Medical Inc. | πΊπΈ United States | US-MF-000047086 |
Manufacturers
Vektor Medical Inc.
Manufacturer
πΊπΈ United States
docjo GmbH
Manufacturer
π¨π Switzerland
Luciole Medical AG
Manufacturer
π¨π Switzerland·5 Basic UDI-DIs·13 Devices
Lobeck Medical AG
Manufacturer
π¨π Switzerland
Abionic SA
Manufacturer
π¨π Switzerland·1 Basic UDI-DI·1 Device·4 Importers
Asecud SA
Manufacturer
π¨π Switzerland
Lambda Health System SA
Manufacturer
π¨π Switzerland
Diagramma AG
Manufacturer
π¨π Switzerland·1 Importer
Aleva Neurotherapeutics SA
Manufacturer
π¨π Switzerland·13 Basic UDI-DIs·13 Devices·DEKRA Certification B.V.
SurgiBox Inc.
Manufacturer
πΊπΈ United States
Gondola Medical Technologies SA
Manufacturer
π¨π Switzerland
veldana medical S.A.
Manufacturer
π¨π Switzerland
Fabrinal SA
Manufacturer
π¨π Switzerland·4 Importers
Microba Pty Ltd
Manufacturer
π¦πΊ Australia
Phagenesis Ltd
Manufacturer
2 Basic UDI-DIs·2 Devices·1 Importer
Resistell AG
Manufacturer
π¨π Switzerland
Lucid Diagnostics
Manufacturer
πΊπΈ United States
Aktiia SA
Manufacturer
π¨π Switzerland·3 Basic UDI-DIs·3 Devices
Rheon Medical SA
Manufacturer
π¨π Switzerland·1 Importer
Smartcanula LLC
Manufacturer
π¨π Switzerland·3 Importers
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| AIMDD Annex II (excluding section 4) | 2223241CE01 | Aleva Neurotherapeutics SA | DEKRA Certification B.V. | Expired |
Devices
RheoLity 2.4
Device
EU MDR
·
Eu Md Class 2a
·Luciole Medical AG·No longer on the market·4 countries
RheoLity 2.6
Device
EU MDR
·
Eu Md Class 2a
·Luciole Medical AG·On the market·4 countries
RheoPatch Sensor 2.0
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoPatch Knob with cable 2.0, 3 meters
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoPatch Knob with cable 2.0, 2 meters
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoPatch Knob with cable 2.0, 1 meter
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoConnect 1.0 General Electric Longer
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoConnect 1.0 General Electric
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoConnect 1.0 Philips
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoConnect 1.0 Philips Longer
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoConnect 1.0 DrΓ€ger Longer
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoConnect 1.0 DrΓ€ger
Device
EU MDR
·
Eu Md Class 1
·Luciole Medical AG·On the market·4 countries
RheoControl
Device
EU MDR
·
Eu Md Class 2a
·Luciole Medical AG·On the market·4 countries
abioSCOPE
Device
EU IVDR
·
Eu Ivd Class A
·Abionic SA·On the market·6 countries
directSTIM Port Plug
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Power Cord
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Adjustable Harness
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Charging Paddle
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Magnet
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Tunneling Tool
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Trial Cable
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM External Pulse Generator
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Patient Programmer Charger kit
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM Clinician Programmer
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM 12-connector extension
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM 24-channel Implantable Pulse Generator
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
directSTIM 12-electrode lead
Device
EU AIMDD
·
Eu Aimdd Class
·Aleva Neurotherapeutics SA·On the market
Phagenyx
Device
EU MDR
·
Eu Md Class 2a
·Phagenesis Ltd·On the market·6 countries
Phagenyx
Device
EU MDR
·
Eu Md Class 2a
·Phagenesis Ltd·On the market·6 countries
Hilo Band (Aktiia Bracelet G1)
Device
EU MDR
·
Eu Md Class 2a
·Aktiia SA·On the market·1 country
Hilo Spot (Aktiia Bracelet G2)
Device
EU MDR
·
Eu Md Class 2a
·Aktiia SA·On the market·1 country
Hilo App (Aktiia G2C Mobile Application)
Device
EU MDR
·
Eu Md Class 2a
·Aktiia SA·On the market·1 country