EC Certificate - Radim S.p.A.
EC Certificate - Radim S.p.A.
EC Certificate - Radim S.p.A.
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<strong>EC</strong> Gertificate<br />
Full Quality Assurance System<br />
Directive 98/79/<strong>EC</strong> on In Vitro Diagnostic Medical Devices (IVDD), Annex lV excluding (4, 6)<br />
(List A and B and devices for self-testing)<br />
No. V1 11 07 51030 009<br />
Manufacturer: <strong>Radim</strong> s.p.a.<br />
Via DelMare 125<br />
00040 Pomezia (ROMA)<br />
ITALY<br />
Product<br />
Reagents for determination of<br />
Category(ies): PSA and infectious diseases<br />
The Certification Body of TÚV SÚD Product Service GmbH declares that the aforementioned<br />
manufacturer has implemented a quality assurance system for design, manufacture and final<br />
inspection of the respective devices / device families in accordance with IVDD Annex lV. This<br />
quality assurance system conforms to the requirements of this Directive and is subject to<br />
periodical surveillance. For marketing of List A devices an additionalAnnex lV (4) certificate<br />
is mandatory. See also notes overleaf.<br />
RepoÉ No.: 1T4212179<br />
Valid from:<br />
Valid until:<br />
Date, 2011-08-30<br />
201 1-08-1 I<br />
201 3-1 0-1 6<br />
TÚV SUD Product Service GmbH is Notified Body with identiflcation no. 0123<br />
Page 1 of 2<br />
Hans-Heiner Junker<br />
TÚV SÚD Product Service GmbH . Zertifizierstelle . RidlerstraBe 65 . 80339 Múnchen Germanv<br />
I<br />
Product Service<br />
TUV@
<strong>EC</strong> <strong>Certificate</strong><br />
Full Quality Assurance System<br />
Directive 98/79/<strong>EC</strong> on In Vitro Diagnostic Medical Devices (IVDD), Annex lV excluding (4, 6)<br />
(List A and B and devices for self-testing)<br />
No. V1 11 07 51030 009<br />
Model(s): Toxoplasma lgG EIA Well<br />
Toxoplasma lgG Avidity EIA Well<br />
Toxoplasma lgM EIA Well<br />
Rubella lgG EIA Well<br />
Rubella lgG Avidità EIA Well<br />
Rubella lgM EIA Well<br />
Cytomegalovirus lgG EIA Well<br />
Gytomegalovirus lgG Avidity EIA Well<br />
Cytomegalovirus lgM EIA Well<br />
Chlamydia lgA EIA Well<br />
Chlamydia lgG EIA Well<br />
PSA EIA<br />
PSA Free EIA<br />
RAD Toxoplasma lgG<br />
RAD Toxoplasma lgG Avidity<br />
RAD Toxoplasma lgM<br />
RAD Rubella lgG<br />
RAD Rubella lgG Avidity<br />
RAD Rubella lgM<br />
RAD CMV lgG<br />
RAD CMV lgG Avidity<br />
RAD CMV lgM<br />
RAD PSA<br />
RAD PSA Free<br />
Galibrator Pack Toxoplasma lgG<br />
Galibrator Pack Toxoplasma lgM<br />
Calibrator Pack Rubella lgG<br />
Calibrator Pack Rubella lgM<br />
Galibrator Pack GMV lgG<br />
Calibrator Pack CMV lgM<br />
Calibrator Pack PSA<br />
Calibrator Pack PSA Free<br />
Ghlamydia Pneumoniae lgA E.W.<br />
Chlamydia Pneumoniae lgG E.W.<br />
Chlamydia Pneumoniae lgM E.W.<br />
TORCH lgG GH<strong>EC</strong>K<br />
TORCH lgG Neg CH<strong>EC</strong>K<br />
TORCH lgM CH<strong>EC</strong>K<br />
TUMORFIT LEVI<br />
TUMORFIT LEV2<br />
Facility(ies):<br />
Page2 of 2<br />
<strong>Radim</strong> s.p.a.<br />
Via Del Mare 125,00040 Pomezia (ROMA), ITALY<br />
TUV SUD Product Service GmbH . Zertifizierstelle RidlerstraBe 65 ' 80339 Miinc[en Germany<br />
a,<br />
Product Service<br />
TJV@
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