Authorized Representative
๐ฉ๐ช Germany
Active
NIHON KOHDEN EUROPE GmbH
SRN: DE-AR-000010740
ยท
Raiffeisenstrasse 10, 61191 Rosbach, Germany
Manufacturers
8
Devices
39
Certificates
1
PRRCs
1
Basic Information
- Address
- Raiffeisenstrasse 10, 61191 Rosbach, Germany
- [email protected]
- Phone
- +49 6003 8270
- Website
- https://eu.nihonkohden.com/
- VAT Number
- DE 114 193 230
- Trade Register
- Friedberg HRB 5808
- EORI
- DE2486369
Non-EU Manufacturers
| Name | Country | SRN |
|---|---|---|
| SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP. | ๐จ๐ณ China | CN-MF-000013567 |
| NIHON KOHDEN MALAYSIA SDN. BHD. | ๐ฒ๐พ Malaysia | MY-MF-000013570 |
| NIHON KOHDEN CORPORATION | ๐ฏ๐ต Japan | JP-MF-000019022 |
| Nihon Kohden Middle East (Branch) | ๐ฆ๐ช United Arab Emirates | AE-MF-000021274 |
| Neurotronics, LLC | ๐บ๐ธ United States | US-MF-000030839 |
| Nihon Kohden Digital Health Solutions LLC | ๐บ๐ธ United States | US-MF-000042132 |
| Nihon Kohden OrangeMed, LLC | ๐บ๐ธ United States | US-MF-000019023 |
| NIHON KOHDEN INDIA PRIVATE LIMITED | ๐ฎ๐ณ India | IN-MF-000045419 |
Manufacturers
Neurotronics, LLC
Manufacturer
๐บ๐ธ United States·8 Basic UDI-DIs·38 Devices·1 Importer·DNV Product Assurance AS
NIHON KOHDEN CORPORATION
Manufacturer
๐ฏ๐ต Japan·1 Basic UDI-DI·1 Device·3 Importers
Nihon Kohden Middle East (Branch)
Manufacturer
๐ฆ๐ช United Arab Emirates·1 Importer
NIHON KOHDEN INDIA PRIVATE LIMITED
Manufacturer
๐ฎ๐ณ India
NIHON KOHDEN MALAYSIA SDN. BHD.
Manufacturer
๐ฒ๐พ Malaysia·1 Importer
Nihon Kohden Digital Health Solutions LLC
Manufacturer
๐บ๐ธ United States·1 Importer
Nihon Kohden OrangeMed, LLC
Manufacturer
๐บ๐ธ United States·1 Importer
SHANGHAI KOHDEN MEDICAL ELECTRONIC INSTRUMENT CORP.
Manufacturer
๐จ๐ณ China·1 Importer
Certificates
| Type | Number | Manufacturer | Notified Body | Status |
|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 10000463613-PA-NA-NOR | Neurotronics, LLC | DNV Product Assurance AS | Expired |
Devices
POLYSOMNOGRAPHS
Device
EU MDD
·
Eu Md Class 2a
·Neurotronics, LLC·On the market·1 country
POLYSOMNOGRAPHS
Device
EU MDD
·
Eu Md Class 2a
·Neurotronics, LLC·On the market·1 country
POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
Device
EU MDD
·
Eu Md Class 2a
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - MEDICAL DEVICE SOFTWARE
Device
EU MDD
·
Eu Md Class 2a
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
Device
EU MDR
·
Eu Md Class 1
·Neurotronics, LLC·On the market·2 countries
Central Monitor CNS-2101
Device
EU MDR
·
Eu Md Class 2b
·NIHON KOHDEN CORPORATION·On the market·32 countries