Instruction for Use

IFU

• PRO-LONG TUBE HEIDELBERGER 30 / 75 / 140 / 190
• Heidelberger Extension Line Group
• Transfusion Set group
• Coro Spike
• Transfer Needle
• IV Set Group
• Perfusion & PE Extension Line Group
• Combi Stopper

Declarations of Conformity

DoC

• DECLARATION OF CONFORMITY 3-WAY-PRO
• DECLARATION OF CONFORMITY INFU-PRO
• DECLARATION OF CONFORMITY PRO-LONG TUBE
• DECLARATION OF CONFORMITY PRO-OMNIA LOCK
• DECLARATION OF CONFORMITY TRASFU-PRO

Production List

PL

• Accesoires 3-WAY STOPCOCK
• Accesoires 3-WAY STOPCOCK+10CM TUBING
• Extension line CLINIX LINE 450
• Extension line CLINIX LINE 1800
• Accesoires COMBISTOPPER
• Accesoires COROSPIKE BLUE
• Accesoires COROSPIKE GREEN
• Accesoires COROSPIKE RED
• Infusion set DUODROP D1 Classic
• Infusion DUODROP D2 protect
• Infusion DUODROP D2/RV protect
• Extension line HEIDELBERGER 75 PRO-LONG TUBE
• Extension HEIDELBERGER 140 PRO-LONG TUBE
• Extension PERFUSION LINE 150 DEHP FREE
• Extension PERFUSION LINE 200 DEHP FREE
• Infusion set ECO DROP S3 Infu Pro
• Infusion set SOLUCARE 180 Infu Pro
• Infusion set SOLUCARE RV 180 Infu Pro
• Accesoires TRANSFER NEEDLE PRO-OMNIA LOCK
• Tranfusion set UNOHEM TRASFU-PRO

Certifications

CE

• Notified Body Confirmation Letter Reference: contract n. 000147909/24
• CE certificate 0425-MED-004456-00
• REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023
• CE EN ISO 13485:2016
• Nařízení EU parlamentu a rady 2017/45 (CZ)
• VERORDNUNG (EU) 2017/745 DES EUROPÄISCHEN PARLAMENTS UND DES RATES vom 5. April 2017 (DE)
• REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 (ENG)
• EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS