EU Manufacturer
🇪🇸 Spain
Active
i+Med S.Coop.
SRN: ES-MF-000008633
·
Parque Tecnológico de Álava, C/Albert Einstein 15, Pab 15, 01510 Vitoria-Gasteiz, Spain
Basic UDI-DIs
21
Total Devices
26
On Market
26
Off Market
0
Certificates
7
Valid
0
Expiring < 6mo
0
Countries
3
Basic Information
- Address
- Parque Tecnológico de Álava, C/Albert Einstein 15, Pab 15, 01510 Vitoria-Gasteiz, Spain
- [email protected]
- Phone
- +34 945 56 11 34
- Website
- https://imasmed.com/
Regulatory Overview
Regulation
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Eu Mdd
19
Eu Mdr
2
Classification
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Eu Md Class 3
10
Eu Md Class 2a
8
Eu Md Class 2b
3
Device Types
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Certificate Health
Total
7
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
5
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | CE666288 | BSI Group The Netherlands B.V. | Feb 03, 2020 | |||
| MDD Annex II (excluding section 4) | 2020 07 0931 CT | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | May 14, 2021 | |||
| MDD Annex II (excluding section 4) | 2021 05 0959 CT | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | May 24, 2021 | |||
| MDD Annex II Section 4 | CE666920 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE-666290 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2021 05 0960 CT | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | Dec 31, 2027 | |||
| MDD Annex II (excluding section 4) | 2021 05 0960 CT | CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS | Dec 31, 2027 |
Market Presence
Devices from this manufacturer are available in 3 countries across Europe.
🇪🇸 Spain
🇫🇷 France
🇵🇱 Poland
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Profilm Aftas Bucales (5ml) | EU MDR | Eu Md Class 2a | On Market | 0 |
| BtHCROSS 1.5% | EU MDD | Eu Md Class 3 | On Market | 1 |
| BtHCROSS 1.75% | EU MDD | Eu Md Class 3 | On Market | 1 |
| BtHCROSS 2.0% | EU MDD | Eu Md Class 3 | On Market | 1 |
| BtHLINE 1.4% | EU MDD | Eu Md Class 3 | On Market | 1 |
| DayDrop 15ud x 0.4ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| DayDrop 20ud x 0.4ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| DayDrop 30ud x 0.4ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| DayDrop 5ud x 0.4ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| HAXL ONE | EU MDD | Eu Md Class 3 | On Market | 1 |
| HAXL ONE | EU MDD | Eu Md Class 3 | On Market | 1 |
| OpHLINE 1.4% | EU MDD | Eu Md Class 2b | On Market | 1 |
| OpHLINE 2.0% | EU MDD | Eu Md Class 2b | On Market | 1 |
| OpHLINE 3.0% | EU MDD | Eu Md Class 2b | On Market | 1 |
| Profilm Aftas Bucales (10ml) AD | EU MDR | Eu Md Class 2a | On Market | 0 |
| Profilm Aftas Bucales (10ml) AR | EU MDR | Eu Md Class 2a | On Market | 0 |
| Profilm Aftas Bucales (5ml) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Profilm Aftas Bucales (5ml) AD | EU MDR | Eu Md Class 2a | On Market | 0 |
| Profilm Aftas Bucales (5ml) AR | EU MDR | Eu Md Class 2a | On Market | 0 |
| Profilm Herpes Labial (10ml) | EU MDR | Eu Md Class 2a | On Market | 0 |
| Profilm Herpes Labial (5ml) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Profilm Herpes Labial 5mL | EU MDR | Eu Md Class 2a | On Market | 0 |
| TrHCROSS 2.0% | EU MDD | Eu Md Class 3 | On Market | 1 |
| TrHCROSS 2.0% | EU MDD | Eu Md Class 3 | On Market | 1 |
| TrHLINE 1.0% | EU MDD | Eu Md Class 3 | On Market | 1 |
| TrHLINE 2.0% | EU MDD | Eu Md Class 3 | On Market | 1 |