EU Manufacturer
🇪🇸 Spain
Active
BIOLAN HEALTH, S.L.
SRN: ES-MF-000001992
·
Parque Tecnológico de Bizkaia, Laida bidea 409, 48170 Zamudio, Spain
Basic UDI-DIs
12
Total Devices
12
On Market
12
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Parque Tecnológico de Bizkaia, Laida bidea 409, 48170 Zamudio, Spain
- [email protected]
- Phone
- +34 946 574 161
- Website
- www.biolanhealth.com
Regulatory Overview
Regulation
Loading...
Eu Ivdd
11
Eu Ivdr
1
Classification
Loading...
Eu Ivd General
8
Eu Ivd Self Testing
3
Eu Ivd Class A
1
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Expired / Withdrawn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) | 2022 04 0975 CT | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇪🇸 Spain
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| COVID-19 Antigen Rapid Test | EU IVDD | Eu Ivd General | On Market | 0 |
| COVID-19 Antigen Rapid Test | EU IVDD | Eu Ivd General | On Market | 0 |
| COVID-19 Antigen Rapid Test | EU IVDD | Eu Ivd General | On Market | 0 |
| COVID-19 Antigen Rapid Test Kit Control | EU IVDD | Eu Ivd General | On Market | 0 |
| COVID-19 Antigen Rapid Test. Self Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| COVID-19 Antigen Rapid Test. Self Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| COVID-19 Antigen Rapid Test. Self Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| COVID-19 lgG/IgM Rapid Test Cassette | EU IVDD | Eu Ivd General | On Market | 0 |
| OSAXYL 7000 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| OSAXYL Control Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| OSAXYL TEST STRIPS | EU IVDD | Eu Ivd General | On Market | 0 |
| OSAXYL TEST STRIPS | EU IVDD | Eu Ivd General | On Market | 0 |