Authorized Representative
π³π± Netherlands
Active
Rexxam Co., Ltd. Netherlands Office
SRN: NL-AR-000002643
Β·
Steenovenweg 5, 5708HN Helmond, Netherlands
Manufacturers
4
Devices
18
Certificates
2
PRRCs
2
Basic Information
- Address
- Steenovenweg 5, 5708HN Helmond, Netherlands
- [email protected]
- Phone
- +31 6 22993911
- Website
- www.rexxam.co.jp
- Trade Register
- 78274370
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| Ohira Co.,Ltd. | π―π΅ Japan | JP-MF-000004195 |
| FINDEX Inc. | π―π΅ Japan | JP-MF-000028068 |
| TOWA MEDICAL INSTRUMENTS CO.,LTD. | π―π΅ Japan | JP-MF-000004196 |
| Rexxam Co.,Ltd | π―π΅ Japan | JP-MF-000004361 |
Manufacturers
FINDEX Inc.
Manufacturer
π―π΅ Japan·1 Basic UDI-DI·1 Device·8 Importers
TOWA MEDICAL INSTRUMENTS CO.,LTD.
Manufacturer
π―π΅ Japan·4 Basic UDI-DIs·4 Devices·15 Importers·SGS FIMKO OY
Rexxam Co.,Ltd
Manufacturer
π―π΅ Japan·3 Basic UDI-DIs·6 Devices·18 Importers
Ohira Co.,Ltd.
Manufacturer
π―π΅ Japan·3 Basic UDI-DIs·7 Devices·15 Importers·SGS Belgium NV
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex V | FI19/819943382 | TOWA MEDICAL INSTRUMENTS CO.,LTD. | SGS FIMKO OY | Expired |
| MDR QMS | JP22/00000336 | Ohira Co.,Ltd. | SGS Belgium NV | Issued |
Devices
Eye-Tracking Perimeter FIELDNavigator
Device
EU MDR
·
Eu Md Class 1
·FINDEX Inc.·On the market·30 countries
CP-500
Device
EU MDD
·
Eu Md Class 1
·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market
BR-7
Device
EU MDD
·
Eu Md Class 1
·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market
TF-3
Device
EU MDD
·
Eu Md Class 1
·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market·19 countries
PD-82II
Device
EU MDD
·
Eu Md Class 1
·TOWA MEDICAL INSTRUMENTS CO.,LTD.·On the market·3 countries
LCD chart LCD-1000
Device
EU MDR
·
Eu Md Class 1
·Rexxam Co.,Ltd·On the market·32 countries
LCD chart LCD-1000P
Device
EU MDR
·
Eu Md Class 1
·Rexxam Co.,Ltd·On the market·32 countries
SLIT LAMP RS-300
Device
EU MDR
·
Eu Md Class 1
·Rexxam Co.,Ltd·On the market·32 countries
SLIT LAMP RS-5000
Device
EU MDR
·
Eu Md Class 1
·Rexxam Co.,Ltd·On the market·32 countries
SLIT LAMP RS-500
Device
EU MDR
·
Eu Md Class 1
·Rexxam Co.,Ltd·On the market·32 countries
Digital Ref-Ractor DR-900
Device
EU MDR
·
Eu Md Class 1
·Rexxam Co.,Ltd·On the market·32 countries
Applanation Tonometer SL-TM
Device
EU MDR
·
Eu Md Class 1
·Ohira Co.,Ltd.·On the market·32 countries
Applanation Tonometer SL-TM
Device
EU MDR
·
Eu Md Class 1
·Ohira Co.,Ltd.·On the market·32 countries
Applanation Tonometer SL-TM
Device
EU MDR
·
Eu Md Class 1
·Ohira Co.,Ltd.·On the market·32 countries
Applanation Tonometer SL-TM
Device
EU MDR
·
Eu Md Class 1
·Ohira Co.,Ltd.·On the market·32 countries
LED Slit Lamp XL-1
Device
EU MDR
·
Eu Md Class 1
·Ohira Co.,Ltd.·On the market·32 countries
Slit Lamp SL-102
Device
EU MDR
·
Eu Md Class 1
·Ohira Co.,Ltd.·On the market·32 countries
Slit Lamp SL-203
Device
EU MDR
·
Eu Md Class 1
·Ohira Co.,Ltd.·On the market·32 countries