Authorized Representative
🇳🇱 Netherlands
Active
MedR-AR Services B.V.
SRN: NL-AR-000000120
·
Kloosterweg 1, 6412 CN Heerlen, Netherlands
Manufacturers
13
Devices
31
Certificates
4
PRRCs
2
Basic Information
- Address
- Kloosterweg 1, 6412 CN Heerlen, Netherlands
- [email protected]
- VAT Number
- NL8605.26.859.B.01
- Trade Register
- Chamber of Commerce 76154076
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Viseon Inc. | 🇺🇸 United States | US-MF-000019135 |
| Zurich Medical | 🇺🇸 United States | US-MF-000012091 |
| Imricor Medical Systems, Inc. | 🇺🇸 United States | US-MF-000017310 |
| Vascular Dynamics, Inc. | 🇺🇸 United States | US-MF-000015549 |
| Artio Medical Corporation | 🇺🇸 United States | US-MF-000017283 |
| DxTx Medical, Inc. | 🇺🇸 United States | US-MF-000026795 |
| MiRTLE Medical LLC | 🇺🇸 United States | US-MF-000026732 |
| Vascular Dynamics, Inc. | 🇺🇸 United States | US-MF-000045576 |
| Saluda Medical Pty Ltd | 🇦🇺 Australia | AU-MF-000010522 |
| Ivantis, Inc. | 🇺🇸 United States | US-MF-000008530 |
| Shape Memory Medical Inc | 🇺🇸 United States | US-MF-000008157 |
| Bolt Medical, Inc. | 🇺🇸 United States | US-MF-000045814 |
| ExThera Medical Corporation | 🇺🇸 United States | US-MF-000002234 |
Manufacturers
ExThera Medical Corporation
Manufacturer
🇺🇸 United States·1 Importer
DxTx Medical, Inc.
Manufacturer
🇺🇸 United States·9 Basic UDI-DIs·9 Devices·GMED SAS
MiRTLE Medical LLC
Manufacturer
🇺🇸 United States·1 Importer
Artio Medical Corporation
Manufacturer
🇺🇸 United States
Ivantis, Inc.
Manufacturer
🇺🇸 United States
Bolt Medical, Inc.
Manufacturer
🇺🇸 United States
Imricor Medical Systems, Inc.
Manufacturer
🇺🇸 United States·1 Importer
Vascular Dynamics, Inc.
Manufacturer
🇺🇸 United States
Zurich Medical
Manufacturer
🇺🇸 United States·2 Importers
Vascular Dynamics, Inc.
Manufacturer
🇺🇸 United States
Viseon Inc.
Manufacturer
🇺🇸 United States
Shape Memory Medical Inc
Manufacturer
🇺🇸 United States·3 Basic UDI-DIs·3 Devices·6 Importers·DQS Medizinprodukte GmbH
Saluda Medical Pty Ltd
Manufacturer
🇦🇺 Australia·19 Basic UDI-DIs·19 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 36594 | DxTx Medical, Inc. | GMED SAS | |
| MDD Annex II (excluding section 4) | 520594 | Shape Memory Medical Inc | DQS Medizinprodukte GmbH | Expired |
| AIMDD Annex II Section 4 | 653955 | Saluda Medical Pty Ltd | BSI Group The Netherlands B.V. | Expired |
| AIMDD Annex II Section 4 | 653955 | Saluda Medical Pty Ltd | BSI Group The Netherlands B.V. | Expired |
Devices
3.0T Ingenia Endorectal Coil Interface Device (eCoil®)
Device
EU MDR
·
Eu Md Class 1
·DxTx Medical, Inc.·On the market·25 countries
Siemens 3.0T Endo Interface II with Tim 4G Slide Connect (e2CoilTM)
Device
EU MDR
·
Eu Md Class 1
·DxTx Medical, Inc.·On the market·9 countries
Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) – Siemens
Device
EU MDR
·
Eu Md Class 1
·DxTx Medical, Inc.·On the market·9 countries
Pro-Tx Endorectal Balloon
Device
EU MDR
·
Eu Md Class 1
·DxTx Medical, Inc.·On the market·15 countries
Siemens 3.0T Endo Interface (eCoil®)
Device
EU MDR
·
Eu Md Class 1
·DxTx Medical, Inc.·On the market·25 countries
Siemens 1.5T Endo Interface (eCoil®)
Device
EU MDR
·
Eu Md Class 1
·DxTx Medical, Inc.·On the market·25 countries
Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®)
Device
EU MDD
·
Eu Md Class 2a
·DxTx Medical, Inc.·On the market·25 countries
1.5T Ingenia Endorectal Coil Interface Device (eCoil®)
Device
EU MDR
·
Eu Md Class 1
·DxTx Medical, Inc.·On the market·25 countries
Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)
Device
EU MDD
·
Eu Md Class 2a
·DxTx Medical, Inc.·On the market·25 countries
IMPEDE-FX Embolization Plug
Device
EU MDD
·
Eu Md Class 2b
·Shape Memory Medical Inc·On the market·32 countries
IMPEDE-FX RapidFill
Device
EU MDD
·
Eu Md Class 2b
·Shape Memory Medical Inc·On the market·32 countries
IMPEDE-FX Embolization Plug
Device
EU MDD
·
Eu Md Class 2b
·Shape Memory Medical Inc·On the market·32 countries
Evoke® Lead Adapter Kit
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Firmware Upgrade Application (FUA)
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Clinical Data Viewer
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Clinical Programming Application (CPA)
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® External Closed Loop Stimulator (eCLS)
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® 12C Trial Percutaneous Lead Kit - 90cm
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® 12C Trial Percutaneous Lead Kit - 60cm
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Spares Kit
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Epidural Needle, 6.5”
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Tunnelling Tool
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® 12C Lead Extension Kit - 55cm
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® 12C Percutaneous Lead Kit - 90cm
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® 12C Percutaneous Lead Kit - 60cm
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Charger (AU)
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Charger (UK)
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Charger (EU)
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Clinical System Transceiver (CST)
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Pocket Console (EPC)
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries
Evoke® Closed-Loop Stimulator (CLS)
Device
EU AIMDD
·
Eu Aimdd Class
·Saluda Medical Pty Ltd·On the market·7 countries