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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Insertion Electrode (IE) Variants; Insertion Test Device (ITD); Magnet Replacement Kit (Replacement Magnet & Non-Magnetic Spacer); Mi1000 MED-EL CONCERT Cochlear Implant; Mi1000 MED-EL CONCERT PIN Cochlear Implant; Mi1200 SYNCHRONY Cochlear Implant; Mi1200 SYNCHRONY PIN Cochlear Implant; PULSAR CI 100; SONATA TI 100 Cochlear Implant; Vibrant Soundbridge
Classification Name: IMPLANT, HEARING, ACTIVE, MIDDLE EAR, PARTIALLY IMPLANTED
Product Code: MPV
Device Class: 3
Registered Establishment Name: ROSE GMBH FUER MEDIZINTECHNIK
Registered Establishment Number: 3002808022
Owner/Operator: Rose GmbH fuer Medizintechnik
Owner/Operator Number: 10042910
Establishment Operations: Contract Sterilizer
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