Subcutaneous neurologic electrodes certification by CE marking according to Council Directive 93/42/EEC concerning medical devices (Q2729958)
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Project Q2729958 in Croatia
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Subcutaneous neurologic electrodes certification by CE marking according to Council Directive 93/42/EEC concerning medical devices |
Project Q2729958 in Croatia |
Statements
88,725.0 Croatian kuna
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105,625.0 Croatian kuna
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85.0 percent
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6 May 2019
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15 March 2020
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SGM d.o.o. za proizvodnju, trgovinu i usluge
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43°30'29.27"N, 16°26'24.68"E
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21000
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Predmet projekta je uvođenje CE ZNAKA za 3 grupe medicinskih proizvoda, IOM elektroda kojima se prati stanje nervnog i mišićnog sustava pacijenta. Proces certifikacije sastoji se od niza testiranja i studija kompatibilnosti, odnosno pripreme tehničke dokumentacije koje prethode samom ishođenju certifikata. Sukladno brojnim novim zahtjevima proizašlim iz DIREKTIVE VIJEĆA 93/42/EEZ, tvrtka je primorana promijeniti sastav i dizajn postojećih proizvoda, kreirati i certificirati nove proizvode, implementirajući nove materijale koji su prihvatljivi novom uredbom. Uvođenje CE ZNAKA za takve, nove proizvode osnovni je preduvjet za daljnju distribuciju proizvoda na tržištu EU. Prihvatljiva ulaganja u projektu su 105.625 Kn. (Croatian)
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The project’s subject matter is a CE marked acquisition of 3 medical devices, IOM electrode monitoring the state of its nervous and muscle systems. The certification process shall consist of a series of tests and compatibility studies, namely the preparation of technical documentation prior to the certificate itself. In line with the numerous new requirements arising from Council Directive 93/42/EEC, the company has to change the composition and design of existing products, create and certify new products, incorporating new materials that are acceptable to the new Regulation. A CE marked introduction for such new products is a basic prerequisite for further distribution of products on the EU market. The eligible investments in the project are 105.625 Kn. (English)
3 June 2021
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Identifiers
KK.03.2.1.12.0018
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