SSCP
Der Kurzbericht über Sicherheit und klinische Leistung (Summary of Safety and Clinical Performance, SSCP) für Brainlab Medizinprodukte der Klasse III liefert vorgesehenen Anwender:innen direkte Informationen zur Sicherheit und klinischen Leistung des Medizinprodukts. Der SSCP enthält eine Zusammenfassung der klinischen Bewertung sowie Informationen zu Indikation, Kontraindikationen, Warnungen und Risiken bezüglich des Medizinprodukts. Darüber hinaus informiert er über Post-Market Surveillance (PMS) und Post-Market Clinical Follow-up (PMCF). Der Kurzbericht wird jährlich aktualisiert.
Der SSCP soll keine allgemeinen Hinweise zur Diagnose oder Behandlung spezieller Krankheiten geben, noch die Hinweise für den Gebrauch als Hauptdokument für den sicheren Gebrauch des Medizinprodukts oder andere Pflichtdokumente ersetzen.
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Disposable Stylet
Summary of Safety and Clinical Performance-Disposable Stylet BG
Summary of Safety and Clinical Performance-Disposable Stylet CS
Summary of Safety and Clinical Performance-Disposable Stylet DA
Summary of Safety and Clinical Performance-Disposable Stylet DE
Summary of Safety and Clinical Performance-Disposable Stylet EL
Summary of Safety and Clinical Performance-Disposable Stylet EN
Summary of Safety and Clinical Performance-Disposable Stylet EP
Summary of Safety and Clinical Performance-Disposable Stylet ES
Summary of Safety and Clinical Performance-Disposable Stylet ET
Summary of Safety and Clinical Performance-Disposable Stylet FI
Summary of Safety and Clinical Performance-Disposable Stylet FR
Summary of Safety and Clinical Performance-Disposable Stylet HR
Summary of Safety and Clinical Performance-Disposable Stylet HU
Summary of Safety and Clinical Performance-Disposable Stylet IT
Summary of Safety and Clinical Performance-Disposable Stylet LT
Summary of Safety and Clinical Performance-Disposable Stylet LV
Summary of Safety and Clinical Performance-Disposable Stylet NL
Summary of Safety and Clinical Performance-Disposable Stylet PL
Summary of Safety and Clinical Performance-Disposable Stylet RO
Summary of Safety and Clinical Performance-Disposable Stylet SK
Summary of Safety and Clinical Performance-Disposable Stylet SL
Summary of Safety and Clinical Performance-Disposable Stylet SV
EM Disposable Stylet
Summary of Safety and Clinical Performance-EM Disposable Stylet BG
Summary of Safety and Clinical Performance-EM Disposable Stylet CS
Summary of Safety and Clinical Performance-EM Disposable Stylet DA
Summary of Safety and Clinical Performance-EM Disposable Stylet DE
Summary of Safety and Clinical Performance-EM Disposable Stylet EL
Summary of Safety and Clinical Performance-EM Disposable Stylet EN
Summary of Safety and Clinical Performance-EM Disposable Stylet EP
Summary of Safety and Clinical Performance-EM Disposable Stylet ES
Summary of Safety and Clinical Performance-EM Disposable Stylet ET
Summary of Safety and Clinical Performance-EM Disposable Stylet FI
Summary of Safety and Clinical Performance-EM Disposable Stylet FR
Summary of Safety and Clinical Performance-EM Disposable Stylet HR
Summary of Safety and Clinical Performance-EM Disposable Stylet HU
Summary of Safety and Clinical Performance-EM Disposable Stylet IT
Summary of Safety and Clinical Performance-EM Disposable Stylet LT
Summary of Safety and Clinical Performance-EM Disposable Stylet LV
Summary of Safety and Clinical Performance-EM Disposable Stylet NL
Summary of Safety and Clinical Performance-EM Disposable Stylet PL
Summary of Safety and Clinical Performance-EM Disposable Stylet RO
Summary of Safety and Clinical Performance-EM Disposable Stylet SK
Summary of Safety and Clinical Performance-EM Disposable Stylet SL
Summary of Safety and Clinical Performance-EM Disposable Stylet SV
Disposable Suction
Summary of Safety and Clinical Performance - Disposable Suction BG
Summary of Safety and Clinical Performance - Disposable Suction CS
Summary of Safety and Clinical Performance - Disposable Suction DA
Summary of Safety and Clinical Performance - Disposable Suction DE
Summary of Safety and Clinical Performance - Disposable Suction EL
Summary of Safety and Clinical Performance - Disposable Suction EN
Summary of Safety and Clinical Performance - Disposable Suction EP
Summary of Safety and Clinical Performance - Disposable Suction ES
Summary of Safety and Clinical Performance - Disposable Suction ET
Summary of Safety and Clinical Performance - Disposable Suction FI
Summary of Safety and Clinical Performance - Disposable Suction FR
Summary of Safety and Clinical Performance - Disposable Suction HR
Summary of Safety and Clinical Performance - Disposable Suction HU
Summary of Safety and Clinical Performance - Disposable Suction IT
Summary of Safety and Clinical Performance - Disposable Suction LT
Summary of Safety and Clinical Performance - Disposable Suction LV
Summary of Safety and Clinical Performance - Disposable Suction NL
Summary of Safety and Clinical Performance - Disposable Suction PL
Summary of Safety and Clinical Performance - Disposable Suction RO
Summary of Safety and Clinical Performance - Disposable Suction SK
Summary of Safety and Clinical Performance - Disposable Suction SL
Summary of Safety and Clinical Performance - Disposable Suction SV