EU Manufacturer
🇨🇳 China
Active
AccuBioTech Co., Ltd.
SRN: CN-MF-000025172
·
Building 4, Maohua Industry Park, No. 1, CAIDA Third Street, Nancai Town, Shunyi District, 101399 Beijing, China
Basic UDI-DIs
6
Total Devices
6
On Market
6
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Building 4, Maohua Industry Park, No. 1, CAIDA Third Street, Nancai Town, Shunyi District, 101399 Beijing, China
- [email protected]
- Phone
- +861080484980
Regulatory Overview
Regulation
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Eu Ivdd
6
Classification
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Eu Ivd Self Testing
6
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Expired / Withdrawn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) | HL 2187098-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| One Step HCG Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| One Step HCG Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| One Step HCG Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| One Step LH Ovulation Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| One Step LH Ovulation Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| One Step LH Ovulation Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |