EU Manufacturer
🇪🇸 Spain
Active
OPKO HEALTH SPAIN S.L.U.
SRN: ES-MF-000014342
·
Plaça d' Europa 13-15, 08908 L'Hospitalet de Llobregat, Spain
Basic UDI-DIs
9
Total Devices
9
On Market
9
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
2
Basic Information
- Address
- Plaça d' Europa 13-15, 08908 L'Hospitalet de Llobregat, Spain
- [email protected]
- Phone
- +34 934099040
Regulatory Overview
Regulation
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Eu Mdd
9
Classification
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Eu Md Class 2b
4
Eu Md Class 3
3
Eu Md Class 2a
2
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | EPG-0176-18 | ISTITUTO SUPERIORE DI SANITA' | Oct 28, 2023 | |||
| MDD Annex III | QCT-0103-18 | ISTITUTO SUPERIORE DI SANITA' | Oct 29, 2023 | |||
| MDD Annex II (excluding section 4) | QCT-0103-08 | ISTITUTO SUPERIORE DI SANITA' | Oct 29, 2023 | |||
| MDD Annex II Section 4 | EPG-0177-18 | ISTITUTO SUPERIORE DI SANITA' | Oct 29, 2023 |
Market Presence
Devices from this manufacturer are available in 2 countries across Europe.
🇧🇬 Bulgaria
🇪🇸 Spain
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Vis Activ Monodose | EU MDD | Eu Md Class 2b | On Market | 1 |
| Vis Activ Neo | EU MDD | Eu Md Class 2b | On Market | 1 |
| Vis Activ Uso Continuo | EU MDD | Eu Md Class 2a | On Market | 1 |
| Vis Glyc Monodosis | EU MDD | Eu Md Class 3 | On Market | 2 |
| Vis Glyc Neo | EU MDD | Eu Md Class 3 | On Market | 2 |
| Vis Glyc Neo | EU MDD | Eu Md Class 3 | On Market | 2 |
| Vis Relax Monodose | EU MDD | Eu Md Class 2b | On Market | 1 |
| Vis Relax Neo | EU MDD | Eu Md Class 2b | On Market | 1 |
| Vis Relax Uso Continuo | EU MDD | Eu Md Class 2a | On Market | 1 |