EU Manufacturer
๐ฉ๐ช Germany
Active
IBL International GmbH
SRN: DE-MF-000015709
ยท
Flughafenstrasse 52A, 22335 Hamburg, Germany
Basic UDI-DIs
23
Total Devices
29
On Market
29
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Flughafenstrasse 52A, 22335 Hamburg, Germany
- [email protected]
- Phone
- + 49 40 5328910
- Website
- www.tecan.com/ibl
Regulatory Overview
Regulation
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Eu Ivdr
21
Eu Ivdd
2
Classification
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Eu Ivd Class B
20
Eu Ivd Annex 2 List B
2
Eu Ivd Class A
1
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | CE665104 | BSI Group The Netherlands B.V. | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 17-OH-Progesterone ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| 17beta-Estradiol Saliva ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| 17beta-Estradiol Saliva Luminescence Immunoassay | EU IVDR | Eu Ivd Class B | On Market | 0 |
| 17beta-Estradiol Saliva Luminescence Immunoassay | EU IVDR | Eu Ivd Class B | On Market | 0 |
| 25-OH-Vitamin D ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Acetylcholine Receptor Autoantibodies (ARAb) RRA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Acetylcholine Receptor Autoantibodies (ARAb) RRA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Acetylcholine Receptor Autoantibodies (ARAb) RRA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| DHEA ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| DHEA Saliva ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Estriol high sensitive Saliva ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Free Testosterone ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Histamine ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Melatonin direct Saliva ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Melatonin-Sulfate Urine ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| MuSK-Ab ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Neopterin ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Phenylalanine (PKU) neonatal Screening Assay | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Phenylalanine (PKU) neonatal Screening Assay | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Progesterone Saliva ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| SaliCap Set | EU IVDR | Eu Ivd Class A | On Market | 0 |
| SaliCap Set | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Serotonin Urine ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Testosterone Saliva ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Testosterone Saliva Luminescence Immunoassay | EU IVDR | Eu Ivd Class B | On Market | 0 |
| Testosterone Saliva Luminescence Immunoassay | EU IVDR | Eu Ivd Class B | On Market | 0 |
| dsDNA-Ab RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| dsDNA-Ab RIA | EU IVDR | Eu Ivd Class B | On Market | 0 |
| sInterleukin-2-Receptor ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |