EU Manufacturer
๐ฉ๐ช Germany
Active
DiaMex GmbH
SRN: DE-MF-000037219
ยท
Siemensstr. 38, 69123 Heidelberg, Germany
Basic UDI-DIs
23
Total Devices
42
On Market
42
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
15
Basic Information
- Address
- Siemensstr. 38, 69123 Heidelberg, Germany
- [email protected]
- Phone
- +49 6221 4166 400
- Website
- www.diamex.com
Regulatory Overview
Regulation
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Eu Ivdd
12
Eu Ivdr
11
Classification
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Eu Ivd Annex 2 List A
12
Eu Ivd Class B
11
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | D1329000041 | MDC MEDICAL DEVICE CERTIFICATION GMBH | May 26, 2025 | |||
| IVDD Annex IV Section 4 | D1329000043 | MDC MEDICAL DEVICE CERTIFICATION GMBH | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 15 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ฎ Slovenia
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Optitrol Blue | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Blue | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Blue | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Blue | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol Blue | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol Blue | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol Green | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Green | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Green | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Green | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol Green | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol Green | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol HEPR-1 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol HEPR-1 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol HEPR-2 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol HEPR-2 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol NAT HBV Screening | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol NAT HBV Screening | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol NAT HEV | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol NAT HEV | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol NAT HIV-2 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol NAT HIV-2 | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol NAT Triplex | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol NAT Triplex | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Orange | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Orange | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Orange | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Red | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Red | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Red | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Red | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol Red | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol Red | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol SeroNeg | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol SeroNeg | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol SeroNeg | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Yellow | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Yellow | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Yellow | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Optitrol Yellow | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol Yellow | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Optitrol Yellow | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |