C E R T I F I C A T E - Welch Allyn
C E R T I F I C A T E - Welch Allyn
C E R T I F I C A T E - Welch Allyn
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C E R T I F I C A T E<br />
DQS GmbH<br />
Deutsche Gesellschaft zur Zertifizierung von Managementsystemen<br />
hereby certifies that the company<br />
<strong>Welch</strong> <strong>Allyn</strong>, Inc.<br />
4341 State Street Road<br />
Skaneateles Falls, NY 13153<br />
USA<br />
for the scope<br />
The design, development, manufacture, distribution and service of finished medical devices, systems,<br />
lighting products and associated components and accessories for use in gastroenterologica<br />
and gynecological endoscopic procedures, cardiopulmonary assessment and intervention, acquiring vital signs<br />
and the examination and test of the eyes, ears, nose, throat and skin<br />
(refer to Attachement for detailed product list)<br />
has implemented and maintains a<br />
Quality Management System.<br />
An audit, documented in a report, has verified that this<br />
quality management system fulfills the requirements<br />
of the following standards:<br />
ISO 13485 : 2003<br />
Quality systems Medical Devices<br />
This certificate is valid until 2011-12-07<br />
(Expiry date)<br />
Certificate Registration No.<br />
(Unique identification code)<br />
314505 MP23CMDR<br />
Frankfurt am Main 2008-12-08<br />
(Effective date)<br />
Ass. iur. M. Drechsel<br />
MANAGING DIRECTORS<br />
Dipl.-Ing. S. Heinloth<br />
D-60433 Frankfurt am Main, August-Schanz-Straße 21<br />
DQS is a CMDCAS (Canadian Medical Devices<br />
Conformity Assessment System) recognized registrar
Annex to Certificate Registration No.: 314505 MP23CMDR,<br />
issued 2008-12-08<br />
page 1 of 2<br />
<strong>Welch</strong> <strong>Allyn</strong>, Inc.<br />
4341 State Street Road<br />
Skaneateles Falls, NY 13153<br />
USA<br />
Location<br />
<strong>Welch</strong> <strong>Allyn</strong>, Inc.<br />
4341 State Street Road<br />
Skaneateles Falls, NY 13153<br />
USA<br />
<strong>Welch</strong> <strong>Allyn</strong>, Inc.<br />
4619 Jordan Road<br />
Skaneateles Falls, NY 13153<br />
USA<br />
Scope<br />
Design and manufacturing<br />
Design and manufacturing<br />
This annex (issued 2008-12-08) is only valid in connection<br />
with the above-mentioned certificate.
Annex to Certificate Registration No.: 314505 MP23CMDR,<br />
issued 2008-12-08<br />
page 2 of 2<br />
<strong>Welch</strong> <strong>Allyn</strong>, Inc.<br />
4341 State Street Road<br />
Skaneateles Falls, NY 13153<br />
USA<br />
List of unambiguous device names covered within the scope of Registration:<br />
Endoscopic:<br />
Ears/Auditory:<br />
Vital Signs:<br />
Eyes/Vision:<br />
Cardiopulmonary:<br />
Anoscope<br />
Colposcope (and colpomicroscope)<br />
Electronic Data and Information Management<br />
Intubating Fiberscope<br />
Laryngoscopes, Rigid<br />
Nasopharyngoscope<br />
Rectal Insufflation Kit<br />
Rhinolaryngoscope<br />
Sigmoidscopes, Flexible<br />
Sigmoidscopes, Rigid<br />
Speculum, Vaginal, Non-Metal<br />
Audiometer<br />
Syringe, Irrigation (Non-dental)<br />
Tester, Auditory Impedance<br />
Calibration Tool<br />
Cuff, Blood Pressure<br />
Monitor, physiological, patient (without arrhythmia<br />
detection or alarms)<br />
Pulse Oximeter Sensor<br />
Pulse Timer<br />
Stethoscope, Electronic<br />
System, Measurement, Blood-Pressure, Non-invasive<br />
Thermometer, Electronic, Clinical<br />
Refractometer, Ophthalmic<br />
Scleral Depressor<br />
Calibration Tool<br />
ECG Cable, Adapter, Electrodes<br />
Spirometer Flow Transducer and<br />
Presser Tubing<br />
Spirometer, diagnostic<br />
System, ECG Analysis<br />
This annex (issued 2008-12-08 is only valid in connection<br />
with the above-mentioned certificate.
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