EU Manufacturer
๐ฏ๐ต Japan
Active
EIKEN CHEMICAL CO., LTD.
SRN: JP-MF-000018097
ยท
4-19-9 Taito, 110-8408 Tokyo, Japan
Basic UDI-DIs
11
Total Devices
38
On Market
38
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
11
Basic Information
- Address
- 4-19-9 Taito, 110-8408 Tokyo, Japan
- [email protected]
Regulatory Overview
Regulation
Loading...
Eu Ivdr
11
Classification
Loading...
Eu Ivd Class C
6
Eu Ivd Class A
4
Eu Ivd Class B
1
Device Types
Loading...
Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 11 countries across Europe.
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ธ๐ฎ Slovenia
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Loopamp(TM) PURE DNA Extraction Kit | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Loopampโข MTBC Detection Kit | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Loopampโข Malaria Pan Detection Kit | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Loopampโข Malaria Pan Detection Kit | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Loopampโข Malaria Pf Detection Kit | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Loopampโข Malaria Pv Detection Kit | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-Auto Sampling Bottle 3 (VCPZ25) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-Auto Sampling Bottle 3 (VCPZ27) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-Auto Sampling Bottle 3 (VCPZ32) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-Auto Sampling Bottle 3 (VCPZ34) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-Auto Sampling Bottle 3 (VCPZ36) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-Auto Sampling Bottle 3 without barcode (VCPZ26) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-Auto Sampling Bottle 3 without barcode (VCPZ30) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-Auto Sampling Bottle 3 without barcode (VCPZ31) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-FCa Calibrator | EU IVDR | Eu Ivd Class B | On Market | 0 |
| OC-FCa Control LV1 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| OC-FCa Control LV2 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| OC-FCa Control LV3 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| OC-FCa Reagent (OC-SENSOR Ceres) | EU IVDR | Eu Ivd Class B | On Market | 0 |
| OC-FCa Reagent (OC-SENSOR PLEDIA) | EU IVDR | Eu Ivd Class B | On Market | 0 |
| OC-FIT Calibrator (for OC-SENSOR DIANA, Micro) | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-FIT Calibrator (for OC-SENSOR PLEDIA, io) | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-FIT Calibrator for OC-SENSOR Ceres | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-FIT Control LV1 | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-FIT Control LV2 | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-FIT Control LV3 | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-Lightโข S FIT Sampling Bottles | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-Lightโข S FIT Test Strips | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-SENSOR Ceres | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-SENSOR FIT Buffer (for OC-SENSOR DIANA, PLEDIA) | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-SENSOR FIT Buffer (for OC-SENSOR io, Micro) | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-SENSOR FIT Latex Reagent (for OC-SENSOR DIANA, PLEDIA) | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-SENSOR FIT Latex Reagent (for OC-SENSOR Micro) | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-SENSOR FIT Latex Reagent (for OC-SENSOR io) | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-SENSOR FIT for OC-SENSOR Ceres | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-SENSOR PLEDIA | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OC-SENSOR Sample Diluent | EU IVDR | Eu Ivd Class C | On Market | 0 |
| OC-SENSOR Sample Diluent (For OC-SENSOR Ceres) | EU IVDR | Eu Ivd Class C | On Market | 0 |