EU Manufacturer
🇨🇳 China
Active
InTec PRODUCTS, INC.
SRN: CN-MF-000023625
·
Xinguang Road 332, 361022 Xiamen, China
Basic UDI-DIs
25
Total Devices
25
On Market
14
Off Market
11
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Xinguang Road 332, 361022 Xiamen, China
- [email protected]
- Phone
- +86 592 680 7228
- Website
- http://www.asintec.com
Regulatory Overview
Regulation
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Eu Ivdd
25
Classification
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Eu Ivd General
17
Eu Ivd Annex 2 List A
8
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV Section 4 | V7 060578 0017 | TÜV SÜD Product Service GmbH | Sep 03, 2024 | |||
| IVDD Annex IV Section 4 | V7 060578 0022 | TÜV SÜD Product Service GmbH | Sep 03, 2024 | |||
| IVDD Annex IV Section 4 | V7 060578 0017 | TÜV SÜD Product Service GmbH | Sep 03, 2024 | |||
| IVDD Annex IV Section 4 | V7 060578 0022 | TÜV SÜD Product Service GmbH | Sep 03, 2024 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| HCV ANTIBODY (TOTAL) | EU IVDD | Eu Ivd Annex 2 List A | Off Market | 1 |
| HCV ANTIBODY (TOTAL) | EU IVDD | Eu Ivd Annex 2 List A | On Market | 1 |
| HCV ANTIBODY (TOTAL) | EU IVDD | Eu Ivd Annex 2 List A | Off Market | 1 |
| HCV ANTIBODY (TOTAL) | EU IVDD | Eu Ivd Annex 2 List A | On Market | 1 |
| HIV MULTIPLE ANTIBODY | EU IVDD | Eu Ivd Annex 2 List A | Off Market | 1 |
| HIV MULTIPLE ANTIBODY | EU IVDD | Eu Ivd Annex 2 List A | Off Market | 1 |
| HIV MULTIPLE ANTIBODY | EU IVDD | Eu Ivd Annex 2 List A | On Market | 1 |
| HIV MULTIPLE ANTIBODY | EU IVDD | Eu Ivd Annex 2 List A | On Market | 1 |
| ONE STEP Anti-Dengue (IgM & IgG) Tri-line Test | EU IVDD | Eu Ivd General | Off Market | 0 |
| ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST | EU IVDD | Eu Ivd General | Off Market | 0 |
| ONE STEP Anti-TP (Treponema Pallidum/Syphilis) TEST | EU IVDD | Eu Ivd General | On Market | 0 |
| ONE STEP H. pylori Ag Test | EU IVDD | Eu Ivd General | On Market | 0 |
| ONE STEP H. pylori Ag Test | EU IVDD | Eu Ivd General | On Market | 0 |
| ONE STEP Myoglobin/CK-MB-cTnI Combo TEST | EU IVDD | Eu Ivd General | On Market | 0 |
| ONE STEP Troponin I Test | EU IVDD | Eu Ivd General | Off Market | 0 |
| One Step Dengue NS1 Ag Test | EU IVDD | Eu Ivd General | Off Market | 0 |
| Rapid Anti-TB (Mycobacterium Tuberculosis) Test | EU IVDD | Eu Ivd General | Off Market | 0 |
| Rapid Anti-TB (Mycobacterium Tuberculosis) Test | EU IVDD | Eu Ivd General | Off Market | 0 |
| Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test | EU IVDD | Eu Ivd General | On Market | 0 |
| Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test | EU IVDD | Eu Ivd General | On Market | 0 |
| Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test | EU IVDD | Eu Ivd General | On Market | 0 |
| Rapid Dengue Duo (NS1 Ag & IgM/IgG Ab) Test | EU IVDD | Eu Ivd General | On Market | 0 |
| Rapid FOB Test | EU IVDD | Eu Ivd General | On Market | 0 |
| Rapid FOB Test | EU IVDD | Eu Ivd General | Off Market | 0 |
| Rapid Rota-Adenovirus Combo Test | EU IVDD | Eu Ivd General | On Market | 0 |