EU Manufacturer
🇺🇸 United States
Active
Biomerica, Inc.
SRN: US-MF-000015772
·
Von Karman Avenue 17571, 92614 Irvine, CA, United States
Basic UDI-DIs
28
Total Devices
28
On Market
28
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
2
Basic Information
- Address
- Von Karman Avenue 17571, 92614 Irvine, CA, United States
- [email protected]
- Phone
- +1 949 645 2111
- Website
- www.biomerica.com
Regulatory Overview
Regulation
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Eu Ivdd
26
Eu Mdr
1
Eu Ivdr
1
Classification
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Eu Ivd General
16
Eu Ivd Self Testing
8
Eu Ivd Annex 2 List B
2
Eu Md Class 1
1
Eu Ivd Class B
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Expired / Withdrawn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) | 20560 | GMED SAS | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 2 countries across Europe.
🇩🇪 Germany
🇪🇸 Spain
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ACTH (Adrenocorticotropic Hormone) ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Allerquant™ 14G A ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Allerquant™ 14G B ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Allerquant™ 42G A ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Allerquant™ 4G A ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Allerquant™ 4G B ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Allerquant™ 7G A ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Allerquant™ 7G B ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Allerquant™ 90G B ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Aware Breast Self Exam | EU MDR | Eu Md Class 1 | On Market | 0 |
| Calcitonin ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| EPO (Erythropoietin) ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| EZ Detect Colon Disease Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| EZ Detect™ Fecal Occult Blood Test Professional | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| EZ Detect™ Home Test for Hidden Blood in The Stool | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| EZ-PSA Professional PSA Test | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Fortel Ovulation Prediction Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Fortel Ultra Sensitive Pregnancy Midstream 1-Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Fortel Ultra Sensitive Pregnancy Midstream 2-Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Fortel® Kidney Disease (Microalbumin) Screening Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| Fortel® Prostate (PSA) Screening Test | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| Fortel® Ulcer (H. pylori) Screening Test | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GAP IgM Helicobacter pylori ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Intact PTH (Parathyroid Hormone) ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Isletest™ GAD ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Isletest™ IAA ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| Isletest™ ICA ELISA | EU IVDD | Eu Ivd General | On Market | 0 |
| NutriDetect™ 7G A ELISA | EU IVDR | Eu Ivd Class B | On Market | 0 |