EU Manufacturer
🇨🇳 China
Active
Suzhou Hokapi Biomedical Engineering Co., Ltd..
SRN: CN-MF-000013723
·
Building 4, No.8, Jinfeng Road, Science & Technology Park, High Tech New District, 215163 Suzhou, China
Basic UDI-DIs
71
Total Devices
71
On Market
71
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Building 4, No.8, Jinfeng Road, Science & Technology Park, High Tech New District, 215163 Suzhou, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
68
Eu Ivdr
3
Classification
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Eu Ivd General
66
Eu Ivd Class A
3
Eu Ivd Annex 2 List B
2
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 081693 0003 | TÜV SÜD Product Service GmbH | May 26, 2024 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Automatic Blood Grouping Analyzer | EU IVDR | Eu Ivd Class A | On Market | 0 |
| HOKAPI™ CYFRA 21-1 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ AE-180 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| HOKAPI™ AE-200 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| HOKAPI™ AFP | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ ANTI-HEV IGG | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ ANTI-HEV IGM | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ ANTI-TG | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ ANTI-TP | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ ANTI-TPO | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ ANTI-TPO | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ BETA-HCG | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ BETA-HCG | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ BETA2-MG | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ B·R·A·H·M·S PCT | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ C-PEPTIDE | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ CA 125 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ CA 15-3 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ CA 19-9 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ CA 242 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ CA 50 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ CA 724 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ CEA | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ CK MB | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ CRP | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ D-DIMER | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ D-DIMER | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ ESTRADIOL | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ ESTRADIOL | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ FERRITIN | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ FPSA | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| HOKAPI™ FSH | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ FSH | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ FT3 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ FT3 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ FT4 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ FT4 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ HCG | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ HE4 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ HER-2/NEU | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ HS TROPONIN I | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ IL-6 | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ INSULIN | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ LH | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ LH | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ MYOGLOBIN | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ NSE | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ NT-PROBNP | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ PGⅠ | EU IVDD | Eu Ivd General | On Market | 0 |
| HOKAPI™ PGⅡ | EU IVDD | Eu Ivd General | On Market | 0 |