Data / Medical devices / Denmark / Eldon Biologicals A/S
Eldon Biologicals A/S: FDA-registered device maker in GENTOFTE Hovedstaden, Denmark, 1 510(k) clearance
Eldon Biologicals A/S is registered with the FDA (registration 3003783142) in GENTOFTE Hovedstaden, Denmark. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 4, 1979. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003783142
- Address
- Sandtoften 10, GENTOFTE Hovedstaden, Denmark, DK-2820
- Owner or operator
- ELDON BIOLOGICALS A/S (9031770)
- Roles
- Manufacturer
- First device listed
- December 6, 2007
- Registered through
- 2026
- Brand names listed
- DOCTOR'S KIT DKS RhD-25, ELDON BAG 2521-25, ELDON HOME KIT HKA 2511-1, ELDON MILITARY KIT MKA 2521-25, ELDON SCHOOL KIT SK 2511-30, ELDON SCHOOL KIT SKA 2511-30, ELDON SCHOOL KIT SKA 2521-25, ELDONBOX 2511-100 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Test, Automated Blood Grouping And Antibody | KSZ | 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 |
|---|---|---|---|---|---|---|
| May 4, 1979 | K790282 | ELDONCARD | KSZ | Substantially Equivalent | Nordisk Infuser System | accessdata.fda.gov |
Compare with other makers
Updated May 4, 1979. 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.