Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003783142

FEI Number

3003783142

Entity Name

ELDON BIOLOGICALS A/S

City/State/Country

GENTOFTE Hovedstaden, DK

Establishment Address

SANDTOFTEN 10, GENTOFTE Hovedstaden DK-2820, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ELDON BIOLOGICALS A/S (Owner Number: 9031770)

Owner / Operator Contact Address

SANDTOFTEN 10, --, GENTOFTE, DK-84 DK-2820, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K790282

PMA Number

N/A

All Registered Proprietary Names

ONE MAN KIT OKA 2511-1 EldonCard DOCTOR'S KIT DKS RhD-25 ELDONBOX 2521-100 ELDON SCHOOL KIT SK 2511-30 ELDON MILITARY KIT MKA 2521-25 ELDON BAG 2521-25 ELDON SCHOOL KIT SKA 2521-25 ELDON SCHOOL KIT SKA 2511-30 ELDONBOX 2511-100 ELDON HOME KIT HKA 2511-1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	Class 2	864.9175	2007-12-06

Official Correspondent

No official correspondent registered.

US Agent Details

Yariv Sivan Business: Strategic Sales and Marketing LLC dba UnitedPharma Email: yariv@unitedpharma.org Phone: (404) 3285144

Related Public Records

Same Entity

ELDON BIOLOGICALS A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003783142. Last updated year: 2026. Please use registration number 3003783142 when referencing this establishment in official correspondence.