MULTIPLE MANUFACTURED BY RADIOMETER MEDICAL APS

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Request for Information Form	Contact Information
Company Name	RADIOMETER MEDICAL APS
Address	AKANDEVEJ 21
City, State, Zip	BRONSHOJ,
Country	DA
FDA Owner/Operator Phone	45-38-273827
FDA Medical Specialty Code	CH - Clinical Chemistry
FDA Product Code	MQM
FDA Classification Name	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
FDA Device Classification Code	General Controls
FDA Regulation Number	862.1113
FDA Common Generic Name	VARIOUS MODELS OF BLOOD ANALYZERS
FDA Proprietary Device Name	MULTIPLE
FDA Owner / Operator Number	9064213
FDA Owner / Operator Name	DANAHER HOLDING COMPANY APS
FDA Establishment Registration Number	3002807968
FDA Registered Establishment Name	RADIOMETER MEDICAL APS
FDA Operation Code(s)	MM - Manufacturer MS - Specification Developer
FDA Listing Date	05-09-03
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	ABBOTT LABORATORIES 820 MISSION ST. SOUTH PASADENA, CA 91030 US 847-937-6100 / 847-938-3471	NBIL	NEONATAL BILIRUBIN
2	DRAEGER MEDICAL SYSTEMS, INC. 3135 QUARRY RD. TELFORD, PA 18969 US 215-660-2078 / 215-660-2078	JM 103 JAUNDICE METER	JAUNDICE METER
3	INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. LEXINGTON, MA 02421 US 781-861-4467 / 781-861-4467	SYNTHESIS	BILIRUBIN (TOTAL & UNBOUND) TEST SYSTEM
4	KONICA MINOLTA SENSING, INC. 3-91, DAISENNISHIMACHI SAKAI-KU SAKAI, OSAKA, 590-8551 JA 81-72-2413295 / 81-72-2413295	MULTIPLE	VARIOUS MODELS OF JAUNDICE METER SYSTEMS
5	REICHERT INC. 3362 WALDEN AVE. DEPEW, NY 14043 US 716-686-4500 / 716-686-4599	MULTIPLE	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
6	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1001 MURRY RIDGE LN. MURRYSVILLE, PA 15668 US 724-387-4559 / 724-387-4559	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	BILIRUBIN ANALYZER