EU Manufacturer
🇨🇳 China
Active
Atlas Link Technology Co., Ltd.
SRN: CN-MF-000021058
·
Gu’an South Industry Zone, 065500 Langfang, China
Basic UDI-DIs
8
Total Devices
8
On Market
8
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Gu’an South Industry Zone, 065500 Langfang, China
- [email protected]
- Phone
- +86 10 65876159
- Website
- www.atlas-link.com/english
Regulatory Overview
Regulation
Loading...
Eu Ivdd
8
Classification
Loading...
Eu Ivd Self Testing
8
Device Types
Loading...
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 057995 0009 | TÜV SÜD Product Service GmbH | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| HCG - RT & POC | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| HCG - RT & POC | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| HCG - RT & POC | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| LH - RT & POC | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| LH - RT & POC | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| LH - RT & POC | EU IVDD | Eu Ivd Self Testing | On Market | 1 |