Products included in the certificate no - Henry Schein Corporate Brand
Products included in the certificate no - Henry Schein Corporate Brand
Products included in the certificate no - Henry Schein Corporate Brand
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Certificate Number<br />
150 CE<br />
Initial Certification Date<br />
28 July 1997<br />
Certificate Issue Date<br />
27 July 2012<br />
Certificate Expiry Date<br />
27 July 2017<br />
The certification is subject to<br />
<strong>the</strong> organization ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g<br />
<strong>the</strong>ir system <strong>in</strong> compliance<br />
with <strong>the</strong> regulations stated<br />
<strong>in</strong> this <strong>certificate</strong>, allow<strong>in</strong>g<br />
regular assessments and<br />
follow<strong>in</strong>g <strong>the</strong> contracted<br />
requirements of <strong>the</strong> Notified<br />
Body.<br />
This Certificate is for <strong>the</strong><br />
exclusive use of AMTAC’s<br />
client and is provided pursuant<br />
to <strong>the</strong> agreement between<br />
AMTAC and its Client.<br />
AMTAC‘s responsibility and<br />
liability are limited to <strong>the</strong> terms<br />
and conditions of <strong>the</strong><br />
agreement. AMTAC assumes<br />
<strong>no</strong> liability to any party, o<strong>the</strong>r<br />
than to <strong>the</strong> Client <strong>in</strong><br />
accordance with <strong>the</strong><br />
agreement, for any loss,<br />
expense or damage<br />
occasioned by <strong>the</strong> use of this<br />
Certificate. Only <strong>the</strong> Client is<br />
authorized to permit copy<strong>in</strong>g or<br />
distribution of this Certificate.<br />
Any use of <strong>the</strong> AMTAC name<br />
or one of its marks for <strong>the</strong> sale<br />
or advertisement of <strong>the</strong> tested<br />
material, product or service<br />
must first be approved <strong>in</strong><br />
writ<strong>in</strong>g by AMTAC.<br />
EC Certificate<br />
PRODUCTION QUALITY ASSURANCE<br />
Directive 93/42/EEC for Medical Devices, Annex V (OBL)<br />
We hereby declare that an exam<strong>in</strong>ation of <strong>the</strong> under mentioned<br />
production quality assurance system has been carried out follow<strong>in</strong>g<br />
<strong>the</strong> requirements of <strong>the</strong> UK national legislation to which <strong>the</strong><br />
undersigned is subjected, transpos<strong>in</strong>g Annex V of <strong>the</strong> Directive<br />
93/42/EEC on medical devices via an Own <strong>Brand</strong><strong>in</strong>g arrangement.<br />
We certify that <strong>the</strong> production quality system conforms with <strong>the</strong><br />
relevant provisions of <strong>the</strong> aforementioned legislation, and <strong>the</strong> result<br />
entitles <strong>the</strong> organization to use <strong>the</strong> CE 0473 mark<strong>in</strong>g on those<br />
products listed below.<br />
Organization:<br />
HENRY SCHEIN INC<br />
135 Duryea Road, Melville, New York 11747, USA<br />
Medical and dental devices as per attached schedule.<br />
AMTAC Certification Services<br />
Limited is a Notified Body<br />
accord<strong>in</strong>g to Directive<br />
93/42/EEC for medical<br />
devices, with identification<br />
number 0473.<br />
AMTAC Certification Services<br />
Limited<br />
Davy Avenue<br />
K<strong>no</strong>wlhill<br />
Milton Keynes<br />
MK5 8NL, UK<br />
Telephone<br />
+44 (0)1908 857 750<br />
Email: acsl@<strong>in</strong>tertek.com<br />
Authorized Signatory:<br />
AMTAC Certification Services Limited, Milton Keynes, UK<br />
2007-01-24
PRODUCT SCHEDULE FOR CERTIFICATE 150 CE<br />
HENRY SCHEIN INC<br />
HENRY SCHEIN INC PRODUCTS<br />
Dental l<strong>in</strong>ers<br />
Gauze sponges<br />
Evacuators<br />
Burs<br />
Endodontic po<strong>in</strong>ts<br />
Surgical drapes<br />
Suture removal kit<br />
Dental X-Ray film<br />
Endodontic po<strong>in</strong>ts<br />
Dental bond<strong>in</strong>g agents<br />
Dental cements<br />
Dental composites<br />
Dental etch<strong>in</strong>g gel<br />
Dental restorative<br />
Endodontic sealers<br />
Solvents<br />
Dental handpieces<br />
Burs<br />
Endodontic drills<br />
Endodontic files<br />
Endodontic fillers<br />
Endodontic pluggers<br />
Endodontic reamers<br />
Endodontic po<strong>in</strong>ts<br />
Dental crowns<br />
Dental bond<strong>in</strong>g agents<br />
Dental cements<br />
Dental composites<br />
Dental crown/bridge material<br />
Dental etch<strong>in</strong>g gel<br />
Dental l<strong>in</strong>ers<br />
Adhesives<br />
Dis<strong>in</strong>fectants<br />
Gauze sponges<br />
Tongue depressors<br />
Blood lancets<br />
Prophylaxis<br />
Endodontic po<strong>in</strong>ts<br />
Evacuators<br />
Abrasives<br />
Dental X-Ray film<br />
Infusion sets<br />
Labac rylics<br />
Dental alloys<br />
Dental l<strong>in</strong>ers<br />
Orig<strong>in</strong>al Issue Date: 28 July 1997<br />
Authorized Signatory:<br />
Certificate Issue Date: 27 July 2012<br />
Page 1 of 3<br />
AMTAC Certification Services Limited<br />
Davy Avenue, K<strong>no</strong>wlhill, Milton Keynes MK5 8NL, UK<br />
Telephone +44 (0)1908 857 750, Fax +44 (0)1908 857 751, www.<strong>in</strong>tertek-acsl.com Email: acsl@<strong>in</strong>tertek.com<br />
Registered No. 829615 Registered Office
PRODUCT SCHEDULE FOR CERTIFICATE 150 CE<br />
HENRY SCHEIN INC<br />
Endodontic posts<br />
Dental l<strong>in</strong>ers<br />
Dental cements<br />
Dental l<strong>in</strong>ers<br />
Prophylaxis<br />
Dental handpieces<br />
Burs<br />
Orthodontic bands<br />
Orthodontic brackets<br />
Orthodontic Buccal tubes<br />
Orthodontic buttons<br />
Orthodontic clasps<br />
Orthodontic cleats<br />
Orthodontic elastometrics<br />
Orthodontic face bows<br />
Orthodontic lips bumpers<br />
Orthodontic locks<br />
Orthodontic screws<br />
Orthodontic separators<br />
Orthodontic spr<strong>in</strong>gs<br />
Orthodontic stops<br />
Orthodontic ties<br />
Orthodontic wedges<br />
Orthodontic wire<br />
Blood lancets<br />
Endodontic po<strong>in</strong>ts<br />
Dental handpiece accessories<br />
Dental handpieces<br />
Dental cements<br />
Dental alloys<br />
Burs<br />
Dental cements<br />
Evacuators<br />
Endodontic drills<br />
Dental cements<br />
Dental composites<br />
Endondontic posts<br />
Dental composites<br />
Burs<br />
Dental etch<strong>in</strong>g gel<br />
Dental handpiece accessories<br />
Dental handpieces<br />
Endodontic po<strong>in</strong>ts<br />
Cotton balls<br />
Cotton rolls<br />
Dis<strong>in</strong>fectants<br />
Dental Bond<strong>in</strong>g Agents<br />
Dental cements<br />
Orig<strong>in</strong>al Issue Date: 28 July 1997<br />
Authorized Signatory:<br />
Certificate Issue Date: 27 July 2012<br />
Page 2 of 3<br />
AMTAC Certification Services Limited<br />
Davy Avenue, K<strong>no</strong>wlhill, Milton Keynes MK5 8NL, UK<br />
Telephone +44 (0)1908 857 750, Fax +44 (0)1908 857 751, www.<strong>in</strong>tertek-acsl.com Email: acsl@<strong>in</strong>tertek.com<br />
Registered No. 829615 Registered Office
PRODUCT SCHEDULE FOR CERTIFICATE 150 CE<br />
HENRY SCHEIN INC<br />
Dental composites<br />
Hypodermic needles<br />
Prophylaxis<br />
Dental l<strong>in</strong>ers<br />
Endodontic cements<br />
Endodontic po<strong>in</strong>ts<br />
Hypodermic needles<br />
Prophylaxis<br />
Latex surgeons’ gloves<br />
Prophylaxis<br />
Hypodermic needles<br />
Hypodermic syr<strong>in</strong>ges<br />
Gauze sponges<br />
Dental X-Ray film<br />
HENRY SCHEIN INC<br />
PRODUCTS<br />
Burs<br />
Bandages<br />
Dental alloys<br />
Dental bond<strong>in</strong>g agents<br />
Dental etch<strong>in</strong>g gel<br />
Gauze sponges<br />
Surgical blades<br />
Surgical scalpels<br />
Dental handpiece accessories<br />
Dental handpieces<br />
Diag<strong>no</strong>stic <strong>in</strong>struments<br />
Bandages<br />
Hypodermic needles<br />
Gauze sponges<br />
Orig<strong>in</strong>al Issue Date: 28 July 1997<br />
Authorized Signatory:<br />
Certificate Issue Date: 27 July 2012<br />
Page 3 of 3<br />
AMTAC Certification Services Limited<br />
Davy Avenue, K<strong>no</strong>wlhill, Milton Keynes MK5 8NL, UK<br />
Telephone +44 (0)1908 857 750, Fax +44 (0)1908 857 751, www.<strong>in</strong>tertek-acsl.com Email: acsl@<strong>in</strong>tertek.com<br />
Registered No. 829615 Registered Office
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