Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1523456

FEI Number

1523456

Entity Name

RADIOMETER AMERICA, INC.

City/State/Country

Middleburg Heights, OH, US

Establishment Address

6836 Engle Rd, Middleburg Heights, OH 44130, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

RADIOMETER MEDICAL APS (Owner Number: 8020503)

Owner / Operator Contact Address

AAKANDEVEJ 21, --, BROENSHOEJ, DK-84 2700, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAFEPICO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2016-03-07
CBT	Arterial Blood Sampling Kit	Anesthesiology	Class 1	868.1100	1986-04-28

Official Correspondent

Hsiao-Qing Chow

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RADIOMETER MEDICAL APS

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH
3014506106	Radiometer Minneapolis	New Brighton, MN, US
3013513377	Radiometer Solutions Sp. z o.o.	Stargard Zachodniopomorskie, PL
3007490412	Radiometer Sp. z o.o	Stargard Zachodniopomorskie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2008	Radiometer America Inc	2	Pump waste tube for blood gas analysis kit. One yellowish/white rubber tube per plastic bag. Used on ABL800 Flex Series blood gas analyzers.

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2050010	BECKMAN COULTER, INC.	CARLSBAD, CA, US
3008156187	TECHNO-PATH MANUFACTURING LTD.	Ballina Tipperary, IE
2016706	Bio-Rad Laboratories Inc.	IRVINE, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1523456. Last updated year: 2026. Please use registration number 1523456 when referencing this establishment in official correspondence.