EU Manufacturer
🇨🇳 China
Active
Tianjin New Bay Bioresearch Co., Ltd.
SRN: CN-MF-000040564
·
Jianshe Road No.1, 300350 Tianjin, China
Basic UDI-DIs
22
Total Devices
22
On Market
22
Off Market
0
Certificates
3
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Jianshe Road No.1, 300350 Tianjin, China
- [email protected]
- Phone
- +86 022 28751515
Regulatory Overview
Regulation
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Eu Ivdd
22
Classification
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Eu Ivd Self Testing
22
Device Types
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Certificate Health
Total
3
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2012972-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | HL 2012972-1 | TÜV Rheinland LGA Products GmbH | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | SX 2012972-1 | TÜV Rheinland LGA Products GmbH | Mar 11, 2027 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Digital 1 Step Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Digital Ovulation Predictor Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| OneStep Ovulation Predictor Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| OneStep Ovulation Predictor Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| OneStep Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Ovulation Test Strips | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Ovulation Tests | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Ovulation Tests | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Pregnancy Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Pregnancy Test Strips | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Pregnancy Tests | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| QuikPac OneStep HCG Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| QuikPac OneStep LH Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| QuikStrip OneStep HCG Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| QuikStrip OneStep LH Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Suretest Precoce | EU IVDD | Eu Ivd Self Testing | On Market | 2 |
| TEST DE GROSSESSE DÉ TECTION PRÉCOCE | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Test de grossesse | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Test de grossesse | EU IVDD | Eu Ivd Self Testing | On Market | 1 |