CARDIVA VASCADE MVP Manuel D'utilisation page 22

Standard /
Symbol
Regulation*
ISO 15223-1
ISO 15223-1
ISO 15223-1
MD
N/A
N/A
EU MDR
*Standards and Regulations:
ISO 15223-1: Medical devices – Symbols to be used with information to be supplied by the manufacturer.
EU MDR: Regulation (EU) 2017/745, Medical Device Regulation
Patient card and leaflet symbols are defined in the leaflet.
IFU 5686 AE, 2024-04
Standard Reference No. /
Symbol Title
5.4.5 / Contains or
presence of natural rubber
latex & B.2 / Negation
Symbol
5.4.8 / Contains biological
material of animal origin
5.7.7 / Medical device
Prescription Device
Package quantity
The requirements for
accreditation and market
surveillance relating to the
marketing of products / CE
Mark with Notified Body
Reference ####
Definition
Indicates that there is no presence of natural rubber or
dry natural rubber latex as a material of construction
within the medical device or the packaging of a medical
device.
Indicates a medical device that contains biological tissue,
cells or their derivatives, of animal origin.
The item is a medical device.
Device is restricted to sale to or on the order of a
physician.
Quantity of systems in package.
Signifies European conformity (CE) mark.
Indicates conformity of products where the Notified Body
performed conformity assessment. Notified Body
reference # is displayed.
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