Any serious incident that has occurred in relation to the device should be reported to
the manu facturer and the competent authority of the Member State in which the user
and/or patient is established.
Česká republika
Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Praha 10
Štátny ústav pre kontrolu liečiv, Kvetná 1024/11, 821 08
Slovensko
Bratislava
Urząd Rejestracji Produktów Leczniczych, Wyrobów Me-
Polska
dycznych i Produktów Biobójczych, Al. Jerozolimskie 181C,
02-222 Warszawa
Das Bundesinstitut für Arzneimittel und Medizinprodukte,
Deutschland
Kurt Georg Kiesinger Allee 3, 53175 Bonn
Roszdravnadzor, Address: 4, bld. 1, Slavyanskaya Square,
Россия
Moscow, 109074
Ministry of Health Ukraine, 7 Hrushevskoho Street, Kyiv,
Україна
01601
The Therapeutic Goods Administration, 136 Narrabundah
Australia
Lane, Symonston ACT 2609
Manufacturer:
ARIES, a.s., Studenec 309, 512 33 Studenec, Czech Republic
Last reviewed: 17.07.2020