Data / Medical devices / Denmark / Bioporto Diagnostics A/S
Bioporto Diagnostics A/S: FDA-registered device maker in Hellerup Hovedstaden, Denmark, 1 510(k) clearance
Bioporto Diagnostics A/S is registered with the FDA (registration 3010739981) in Hellerup Hovedstaden, Denmark. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 7, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010739981
- Address
- Tuborg Havnevej 15, st, Hellerup Hovedstaden, Denmark, 2900
- Owner or operator
- BioPorto Diagnostics A/S (10089659)
- Roles
- Manufacturer
- First device listed
- December 27, 2023
- Registered through
- 2026
- Brand names listed
- ProNephro AKI (NGAL)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acute Kidney Injury Test System | PIG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 7, 2023 | K232761 | ProNephro AKI (NGAL) | PIG | Substantially Equivalent | Bioporto Diagnostic, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 18, 2026 | 99266 | Class II | Ongoing | ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. | The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users. | accessdata.fda.gov |
Updated August 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.