Hello oliver5565-ga,
I was unable to answer all four of your questions, so am placing the
information I have found in the comment field, since I do not know
whether you consider this sufficient to merit payment as an answer.
It seemed pointless to waste what I have managed to find. Perhaps it
may help another researcher to complete your query.
2.. High technology products related to medicine and health.
Orthopaedic implants and instruments, screws and plates, surgical
drains and catheters, systems for surgical aspiration, prostheses eg
for hip replacement, Bio-Osteo- a non-toxic polymer with elasticity
modulus similar to that of bone for prostheses
(http://www.biomecanica.com.br/english/bioosteo/index.htm) – based on
a plant urethane derived from the castor oil plant, Acrilex, a bone
cement for orthopaedic
use(http://www.biomecanica.com.br/english/acrilex.htm), Hig-Med, a
nontoxic biodegradable cleaner and disinfectant derived from the
castor oil plant (Ricinus communis)
(http://www.biomecanica.com.br/english/higmed.htm), Bio-sponge -
neurosurgical compresses of polyester fiber
(http://www.biomecanica.com.br/english/biosponge.htm). Bio-Tela
knitted mesh interlaced with polyproylene monofilament for repair of
hernias and other types of prolapse
(http://www.biomecanica.com.br/english/biotela.htm )
4. In August 2001, Biomecanica became accredited under ISO 9002:1994
and ISO 13488:1996, as well as getting a Certificate under Directive
93/42/EEC (Medical Device Directive) , the“CE Mark” following an audit
by DNV - Det Norske Veritas Norway. The European Commission refers to
the CE Marking of products as a "passport" which can allow a
manufacturer to freely circulate their products within the European
marketplace. The marking applies only to products regulated by the
European Commission’s health, safety and environmental protection
legislation.
The Brazilian National Agency for Health Protection has licensed
Biomecanica for production and distribution of its products: eg
http://www.anvisa.gov.br/anvisalegis/resol/2001/1763_01re.htm If you
go to the search page of the agency at
http://www.anvisa.gov.br/scriptsweb/correlato/correlato.htm at put in
Biomecanica in the Nome da empresa field for the “Produtos” search,
you will see products of the company which have been licensed at
various times. The dates refer to the expiry of the licenses. |
