Authorized Representative
๐ฎ๐น Italy
Active
Donawa Lifescience Consulting Srl
SRN: IT-AR-000007785
ยท
Piazza Albania 10, 00153 Rome, Italy
Manufacturers
31
Devices
15
Certificates
1
PRRCs
1
Basic Information
- Address
- Piazza Albania 10, 00153 Rome, Italy
- [email protected]
- Phone
- +39 06 578 2665
- Website
- www.donawa.com
- VAT Number
- IT10442731005
- EORI
- IT10442731005
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Hemostasis LLC | ๐บ๐ธ United States | US-MF-000033586 |
| Tenex Health, Inc. | ๐บ๐ธ United States | US-MF-000034123 |
| Qlicksmart Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000033870 |
| Globalcare Medical Technology Co., Ltd. | ๐จ๐ณ China | CN-MF-000033595 |
| Carbon Medical Technologies, Inc. | ๐บ๐ธ United States | US-MF-000044355 |
| Simplivia Healthcare LTD. | ๐ฎ๐ฑ Israel | IL-MF-000035592 |
| CollPlant Ltd. | ๐ฎ๐ฑ Israel | IL-MF-000034347 |
| Genea Biomedx Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000035998 |
| Meridian Bioscience Israel Ltd. | ๐ฎ๐ฑ Israel | IL-MF-000034713 |
| Lexion Medical LLC | ๐บ๐ธ United States | US-MF-000033626 |
| UltraSight LTD | ๐ฎ๐ฑ Israel | IL-MF-000035620 |
| CoAg Medical LLC | ๐บ๐ธ United States | US-MF-000034538 |
| PainChek Ltd. | ๐ฆ๐บ Australia | AU-MF-000034893 |
| Truscreen Limited | ๐ฌ๐ง United Kingdom | GB-MF-000035911 |
| Origin Medical Devices Inc | ๐บ๐ธ United States | US-MF-000037007 |
| FUSMOBILE ISRAEL LTD | ๐ฎ๐ฑ Israel | IL-MF-000037378 |
| GLANCE OPTICAL PTY LTD | ๐ฆ๐บ Australia | AU-MF-000045585 |
| Acorda Therapeutics, Inc. | ๐บ๐ธ United States | US-MF-000033698 |
| CVAID Ltd. | ๐ฎ๐ฑ Israel | IL-MF-000041803 |
| SpectraWAVE, Inc. | ๐บ๐ธ United States | US-MF-000034131 |
| OASIS Medical, Inc. | ๐บ๐ธ United States | US-MF-000034540 |
| Zed Technologies Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000034171 |
| A-dec, Inc. | ๐บ๐ธ United States | US-MF-000034132 |
| WomanCare Global Trading C.I.C., Inc. | ๐บ๐ธ United States | US-MF-000035890 |
| WomanCare Global, LLC | ๐บ๐ธ United States | US-MF-000042625 |
| Bodystat Limited | ๐ฎ๐ฒ Isle of Man | IM-MF-000035330 |
| Mycardium AI Ltd | ๐ฌ๐ง United Kingdom | UK-MF-000042626 |
| TIDALSENSE LIMITED | ๐ฌ๐ง United Kingdom | GB-MF-000035597 |
| Traferox Technologies Inc. | ๐จ๐ฆ Canada | CA-MF-000035752 |
| Anumana, Inc. | ๐บ๐ธ United States | US-MF-000040309 |
| Sirtex Medical Pty Ltd | ๐ฆ๐บ Australia | AU-MF-000035917 |
Manufacturers
Carbon Medical Technologies, Inc.
Manufacturer
๐บ๐ธ United States
Truscreen Limited
ManufacturerBodystat Limited
Manufacturer
๐ฎ๐ฒ Isle of Man·1 Importer
GLANCE OPTICAL PTY LTD
Manufacturer
๐ฆ๐บ Australia
Acorda Therapeutics, Inc.
Manufacturer
๐บ๐ธ United States·1 Basic UDI-DI·1 Device
FUSMOBILE ISRAEL LTD
Manufacturer
๐ฎ๐ฑ Israel·2 Basic UDI-DIs·3 Devices
Genea Biomedx Pty Ltd
Manufacturer
๐ฆ๐บ Australia
Anumana, Inc.
Manufacturer
๐บ๐ธ United States
Qlicksmart Pty Ltd
Manufacturer
๐ฆ๐บ Australia·5 Basic UDI-DIs·9 Devices·4 Importers·TรV SรD Product Service GmbH
Simplivia Healthcare LTD.
Manufacturer
๐ฎ๐ฑ Israel·3 Importers
Sirtex Medical Pty Ltd
Manufacturer
๐ฆ๐บ Australia
WomanCare Global Trading C.I.C., Inc.
Manufacturer
๐บ๐ธ United States·1 Importer
Meridian Bioscience Israel Ltd.
Manufacturer
๐ฎ๐ฑ Israel
Hemostasis LLC
Manufacturer
๐บ๐ธ United States·2 Importers
UltraSight LTD
Manufacturer
๐ฎ๐ฑ Israel
PainChek Ltd.
Manufacturer
๐ฆ๐บ Australia
Zed Technologies Pty Ltd
Manufacturer
๐ฆ๐บ Australia
CollPlant Ltd.
Manufacturer
๐ฎ๐ฑ Israel
SpectraWAVE, Inc.
Manufacturer
๐บ๐ธ United States
Origin Medical Devices Inc
Manufacturer
๐บ๐ธ United States·1 Importer
OASIS Medical, Inc.
Manufacturer
๐บ๐ธ United States·7 Importers
Mycardium AI Ltd
Manufacturer
1 Importer
Globalcare Medical Technology Co., Ltd.
Manufacturer
๐จ๐ณ China·1 Basic UDI-DI·2 Devices·4 Importers
TIDALSENSE LIMITED
ManufacturerWomanCare Global, LLC
Manufacturer
๐บ๐ธ United States·2 Importers
Traferox Technologies Inc.
Manufacturer
๐จ๐ฆ Canada
A-dec, Inc.
Manufacturer
๐บ๐ธ United States·2 Importers
Tenex Health, Inc.
Manufacturer
๐บ๐ธ United States
Lexion Medical LLC
Manufacturer
๐บ๐ธ United States·3 Importers
CVAID Ltd.
Manufacturer
๐ฎ๐ฑ Israel
CoAg Medical LLC
Manufacturer
๐บ๐ธ United States
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex V | G2S 105080 0003 | Qlicksmart Pty Ltd | TรV SรD Product Service GmbH | Expired |
Devices
INBRIJA
Device
EU MDR
·
Eu Md Class 2a
·Acorda Therapeutics, Inc.·On the market·2 countries
Neurolyser XR Gel Pad
Device
EU MDR
·
Eu Md Class 1
·FUSMOBILE ISRAEL LTD·On the market
Neurolyser XR Gel Pad
Device
EU MDR
·
Eu Md Class 1
·FUSMOBILE ISRAEL LTD·On the market·1 country
Neurolyser XR DQA
Device
EU MDR
·
Eu Md Class 1
·FUSMOBILE ISRAEL LTD·On the market·1 country
BladeSINGLE Sterile
Device
EU MDD
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
BladeNeedleSYSTEM Sterile
Device
EU MDD
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
BladeCASSETTE Sterile
Device
EU MDD
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
BladeNeedleSYSTEM Non sterile Single Use Blade Remover
Device
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
BladeSINGLE Non Sterile Blade Remover
Device
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
BladeCASSETTE Non sterile Scalpel Blade Remover
Device
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
BladeBOX
Device
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
BladeFlask EVO
Device
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
Qlicksmart BladeFLASK
Device
EU MDR
·
Eu Md Class 1
·Qlicksmart Pty Ltd·On the market·32 countries
Veroval BPU 22
Device
EU MDR
·
Eu Md Class 2a
·Globalcare Medical Technology Co., Ltd.·On the market·1 country
Veroval BPU 26
Device
EU MDR
·
Eu Md Class 2a
·Globalcare Medical Technology Co., Ltd.·On the market·1 country