EU Manufacturer
๐ฏ๐ต Japan
Active
SYSMEX CORPORATION
SRN: JP-MF-000014037
ยท
Wakinohama-Kaigandori Chuo-ku 1-5-1 , 651-0073 Kobe, Japan
Basic UDI-DIs
121
Total Devices
191
On Market
190
Off Market
1
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Wakinohama-Kaigandori Chuo-ku 1-5-1 , 651-0073 Kobe, Japan
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdr
92
Eu Ivdd
29
Classification
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Eu Ivd Class A
91
Eu Ivd General
29
Eu Ivd Class C
1
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTOMATED URINE ANALYSERS - HARDWARE ACCESSORIES | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUTOMATED URINE ANALYSERS - HARDWARE ACCESSORIES | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AUXILIARY REAGENTS (HAEMOSTASIS) - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BETA-AMYLOID (1-40) | EU IVDD | Eu Ivd General | On Market | 0 |
| BETA-AMYLOID (1-40) | EU IVDD | Eu Ivd General | On Market | 0 |
| BETA-AMYLOID (1-42) | EU IVDD | Eu Ivd General | On Market | 0 |
| BT-40 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BT-50 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA CAL S | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA CAL S | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA CLEAN I | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA CLEAN II | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA CLEAN II | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA CLEAN II | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA CLEAN II | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA-620 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA-620 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA-650 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA-660 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CA-660 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CELL AND TISSUE CULTURES, CONTAINERS - OTHER | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CELLCLEAN | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CELLCLEAN U | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CELLPACK | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CELLPACK | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CELLPACK DCL | EU IVDR | Eu Ivd Class A | On Market | 0 |