EU Manufacturer
🇨🇳 China
Hangzhou Alltest Biotech.Co.,Ltd.
SRN: CN-MF-000010710
·
Yinhai Street #550, 310018 Hangzhou, China
Basic UDI-DIs
119
Total Devices
171
On Market
171
Off Market
0
Certificates
10
Valid
0
Expiring < 6mo
0
Countries
3
Basic Information
- Address
- Yinhai Street #550, 310018 Hangzhou, China
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
97
Eu Ivdr
22
Classification
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Eu Ivd Self Testing
58
Eu Ivd General
33
Eu Ivd Class A
15
Eu Ivd Annex 2 List A
5
Eu Ivd Class B
4
Eu Ivd Class C
3
Eu Ivd Annex 2 List B
1
Device Types
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Certificate Health
Total
10
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
10
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V10951230008 | TÜV SÜD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | No.V1 095123 0008 | TÜV SÜD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CeCert/097/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | CeCert/102/W/E.1 | CeCert Sp. z o.o. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | VCQ0951230013 | TÜV SÜD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | VCQ0951230013 Rev.00 | TÜV SÜD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | No.VCQ 095123 0013 | TÜV SÜD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | No.V1095123 0008 | TÜV SÜD Product Service GmbH | May 26, 2025 | |||
| IVDD Annex III Section 6 | 1434-IVDD-217/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex III Section 6 | 1434-IVDD-035/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Market Presence
Devices from this manufacturer are available in 3 countries across Europe.
🇩🇪 Germany
🇮🇪 Ireland
🇮🇹 Italy
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 16-Channel Fluorescence Immunoassay Analyzer | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Fluorescence Immunoassay Analyzer | EU IVDR | Eu Ivd Class A | On Market | 0 |
| SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test | EU IVDD | Eu Ivd General | On Market | 0 |
| 25-HYDROXYVITAMIN D | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Adenovirus Antigen Rapid Test Cassette | EU IVDD | Eu Ivd General | On Market | 0 |
| Adenovirus Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Adenovirus Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Adenovirus Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Adenovirus Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Adenovirus Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Adenovirus Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Automatic Chemiluminescence Immunoassay Analyzer | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Automatic Chemiluminescence Immunoassay Analyzer | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Blood Glucose Meter Ⅱ | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Blood Glucose Meter Ⅱ | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Blood Glucose Meter Ⅱ | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system I | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Blood Glucose/ Ketone/ Uric Acid/ Total Cholesterol 4 in 1 monitoring system II | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CANCER ANTIGEN 125 | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 15-3 | EU IVDD | Eu Ivd General | On Market | 0 |
| CANCER ANTIGEN 19-9 | EU IVDD | Eu Ivd General | On Market | 0 |
| CLIN. CHEM. RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CLIN. CHEM. RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| COMBINED ABO TYPING + RHESUS D | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CORONAVIRUS [obsolete from 2025-01-01] | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| COVID-19 Antigen Rapid Test | EU IVDD | Eu Ivd General | On Market | 0 |
| Cassette Test Rapide Strep A | EU IVDD | Eu Ivd General | On Market | 0 |
| Chlamydia Rapid Test Cassette | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Cholesterol Test Strips | EU IVDD | Eu Ivd General | On Market | 0 |
| DENGUE - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| DENGUE - RT & POC | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Dengue Combo Rapid Test | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Dengue NS1 Rapid Test (AchieveDx Brand) | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Dry-type Fluorescent Immunoassay Analyzer (Single channel) | EU IVDR | Eu Ivd Class A | On Market | 0 |
| FERRITIN | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| FERRITIN | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| FERRITIN | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| FERTILITY/PREGNANCY RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| FERTILITY/PREGNANCY RT & POC - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| FOB Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FOB Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FOB Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FOB Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FOB Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FOB Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |
| FOB Rapid Test | EU IVDR | Eu Ivd Class B | On Market | 0 |