European CE Compliance for Legacy and HD Implants
DSI Quality Management System is ISO 9001:2015 compliant
DSI's products are compliant with regulations of the markets where our products are sold and distributed, but not limited to EU directives, spectrum management regulations, environmental regulations and safety regulations.
DSI products are developed and tested to assist in supporting additional customer regulations such as FDA, GLP, and FDA part 1 compliance.
R&TTE Declaration of Conformity
We, Data Sciences International (DSI), located at 119 14th Street NW, St. Paul, Minnesota, 55112 USA, declare under our sole responsibility that the products:
are in conformity with the essential requirements and other relevant requirements of the R&TTE Directive (1999/5/EC). The products are compliant with the following standards and/or other normative documents:
SAFETY EN 61010-1:2001
EMISSIONS EN 300-330-2:2001
EMC EN 301-489-1
EN 301-489-3
Supplementary information:
The technical file is held by Data Sciences International, Inc.
Place and date of issue:
119 14th Street NW, Suite 100
St. Paul, Minnesota, 55112 USA
Marketing DSI Europe; France
Part Number | Model Name |
270-0011-xxx | TA10CTA-D70 |
270-0021-xxx | TA11CA-F40 |
270-0023-xxx | TA10TA-F20 |
270-0033-xxx | TA10TA-D70 |
270-0034-xxx | TA10TA-F40 |
270-0036-xxx | TA10EA-F20 |
270-0037-xxx | TA10TA-F40 W/TP |
270-0040-xxx | TA11PA-C40 |
270-0041-xxx | TA11CTA-F40 |
270-0042-xxx | TA10ETA-F20 |
270-0044-xxx | TA11PA-D70 |
270-0066-xxx | TL10M3-F50-EET |
270-0087-xxx | TL10M3-F50-EEE |
270-0091-xxx | TL10M3-D70-EEE |
270-0092-xxx | TL11M2-C50-PXT |
270-0093-xxx | TL11M2-D70-PCT |
270-0124-xxx | TL11M2-F20- EET |
270-0126-xxx | TL11M3-D70-PCTP |
270-0134-xxx | TL11M2-F40-EET |
270-0135-xxx | TA11PA-C10 |
270-0136-xxx | TL11M3-D70-CCTP |
270-0138-xxx | TA11TA-F50 |
270-0147-xxx | TL11M2-F40-TT |
270-0160-xxx | TA11ETA-F10 |
270-0161-xxx | TA11PAC10-TOX |
270-0162-xxx | TA10TA-F10 |
270-0163-xxx | TL11M3-D70-PCTR |
270-0164-xxx | TA11PA-C10-TOX-LA |
270-0165-xxx | TA11PA-C10-TOX-SA |
270-0170-xxx | HD-X11 |
270-0192-xxx | HD-S21 |
270-0193-xxx | HD-S11 |
Comments
0 comments
Please sign in to leave a comment.