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A. Contact2 is FDA registered for sale in the USA.
FDA links of relevance:
FDA establishment registration database listing for Contact2.
Enter Establishment Registration Number 3004127918 or Owner/Operator Number 9057988 where shown
and press "Search"
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/listing.cfm
FDA Premarket notification procedures for contact lens
remover.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=886.5420
A. Manufacture facilities and components are FDA (USA)
and CE (EU) certified.
A. The letters "CE" are the abbreviation of French
phrase "Conformité Européene" which
literaturely means "European Conformity". The
term initially used was "EC Mark" and it was officially
replaced by "CE Marking" in the Directive 93/68/EEC
in 1993. "CE Marking" is now used in all EU official
documents. "CE Mark" is also in use, but it is
NOT the official term.
1. CE Marking on a product is a manufacturer's declaration
that the product complies with the essential requirements
of the relevant European health, safety and environmental
protection legislations, in practice by many of the so-called
Product Directives.* *Product Directives contains the "essential
requirements" and/or "performance levels"
and "Harmonized Standards" to which the products
must conform. Harmonized Standards are the technical specifications
(European Standards or Harmonization Documents) which are
established by several European standards agencies.
2. CE Marking on a product indicates to governmental officials
that the product may be legally placed on the market in
their country.
3. CE Marking on a product ensures the free movement of
the product within the EU single market, and
4. CE Marking on a product permits the withdrawal of the
non-conforming products by customs and enforcement/vigilance
authorities.
A. Contact lens related eye infections are mainly due to
improper hygiene routines.
Contact2 also meets the latest Medicines and Healthcare
products Regulatory agency (UK) advisory on devices that
come into contact with the eye being made disposable.
A. Like many other companies we found Chinese based manufacturers
unbeatable on price without any compromise in quality control.
We pass these savings on.
A. It is made exclusively for us under licence to our exact
specifications. The manufacturers comply with both CE and
FDA certification - ensuring production takes place in a
strictly controlled clean room environment.
As well as Contact2, it also produces various medical products
for many household name companies throughout the world.
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