EU Manufacturer
Active
Alba Bioscience Limited
SRN: GB-MF-000029300
·
James Hamilton Way, Milton Bridge 5, EH26 0BF Penicuik
Basic UDI-DIs
15
Total Devices
15
On Market
15
Off Market
0
Certificates
18
Valid
0
Expiring < 6mo
0
Countries
15
Basic Information
- Address
- James Hamilton Way, Milton Bridge 5, EH26 0BF Penicuik
- [email protected]
- Phone
- 01313373333
- Website
- www.alivedx.com
Regulatory Overview
Regulation
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Eu Ivdd
15
Classification
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Eu Ivd Annex 2 List A
15
Device Types
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Certificate Health
Total
18
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
18
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV Section 4 | 1434-IVDD-120/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-121/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-207/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-208/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-209/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-210/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-122/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-123/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-213/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-214/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-211/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-212/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-124/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 1434-IVDD-125/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-116-2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-117-2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-116_2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 | |||
| IVDD Annex IV Section 4 | 1434-IVDD-116/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Market Presence
Devices from this manufacturer are available in 15 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇨🇿 Czechia
🇩🇪 Germany
🇬🇷 Greece
🇫🇮 Finland
🇫🇷 France
🇮🇪 Ireland
🇮🇹 Italy
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇷🇴 Romania
🇸🇪 Sweden
🇸🇰 Slovakia
🇬🇧 United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ALBAcheck® | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAcheck® | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAclone | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAclone | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAclone | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAclone | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAclone | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAclone | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAclone® | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAclone® Anti-B | EU IVDD | Eu Ivd Annex 2 List A | On Market | 1 |
| ALBAcyte® | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAcyte® | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAcyte® | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAcyte® | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ALBAcyte® | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |