EU Manufacturer
🇩🇪 Germany
Active
Atlas Medical GmbH
SRN: DE-MF-000029961
·
Ludwig-Erhard-Ring 3, 15827 Blankenfelde-Mahlow OT Dahlewitz, Germany
Basic UDI-DIs
179
Total Devices
179
On Market
179
Off Market
0
Certificates
11
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Ludwig-Erhard-Ring 3, 15827 Blankenfelde-Mahlow OT Dahlewitz, Germany
- [email protected]
- Phone
- +4933708355030
- Website
- http://www.atlas-medical.com/
Regulatory Overview
Regulation
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Eu Ivdd
179
Classification
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Eu Ivd General
143
Eu Ivd Annex 2 List A
24
Eu Ivd Self Testing
12
Device Types
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Certificate Health
Total
11
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
11
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex III Section 6 | 16167 | GMED SAS | May 14, 2024 | |||
| IVDD Annex III Section 6 | 16166 | GMED SAS | May 14, 2024 | |||
| IVDD Annex III Section 6 | 16164 | GMED SAS | May 14, 2024 | |||
| IVDD Annex III Section 6 | 16165 | GMED SAS | May 14, 2024 | |||
| IVDD Annex III Section 6 | 37790 | GMED SAS | May 26, 2025 | |||
| IVDD Annex III Section 6 | 39020 | GMED SAS | May 26, 2025 | |||
| IVDD Annex III Section 6 | 38639 | GMED SAS | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 33540 | GMED SAS | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 33544 | GMED SAS | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 33540 | GMED SAS | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 33544 | GMED SAS | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-AB (1/256), Anti-D (1/64)), 4x10ml/carton Box | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-D (1/64)), 3x10ml/ Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-D (1/64)), 3x10ml/carton Box. | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ABO Set (Anti-A (1/256), Anti-B (1/256), Anti-D (1/64)), 3x10ml/plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-AB (1/512) Anti-D (1/128)), 4x10ml, 4vials/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-AB (1/512) Anti-D (1/128)), 4x10ml/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-D (1/128)), 3x10ml/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ABO Set: Anti-A (1/256), Anti-B (1/256), 2x10ml/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ATLAS Home Pregnancy Test strip | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| ATLAS Home Pregnancy strip test with handle | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Anti-A Monoclonal Reagent (Titer: 1/256), 10ml/vial, 1 Vial/carton Box | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-A Monoclonal Reagent (Titer: 1/256), 10ml/vial, 10 vials/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-A Monoclonal Reagent (Titer: 1/512), 10ml/vial. 10 vials/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-AB Monoclonal Reagent (Titer: 1/256), 10ml/vial, 1vial/carton Box | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-AB Monoclonal Reagent (Titer: 1/256), 10ml/vial,10 vials/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-AB Monoclonal Reagent (Titer: 1/512), 10ml/vial, 1 vial/carton Box | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-AB Monoclonal Reagent (Titer: 1/512), 10ml/vial, 10 vials/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-B Monoclonal Reagent (Titer: 1/256), 10ml/vial, 10 vials/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-B Monoclonal Reagent (Titer: 1/256), 10ml/vial, 1vial/carton Box | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-B Monoclonal Reagent (Titer: 1/512), 10ml/vial, 1 vial/carton Box | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-B Monoclonal Reagent (Titer: 1/512), 10ml/vial, 10 vials/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 1 vial/carton Box | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-D IgG/IgM Blend Reagent (Titer: 1/128), 10ml/vial, 10 vials/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 10 vials/Plastic Pack | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Anti-D IgG/IgM Blend Reagent (Titer: 1/64), 10ml/vial, 1Vial/carton Box | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |
| Atlas | EU IVDD | Eu Ivd General | On Market | 0 |