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Accreditation no: 1003
Overview of the organisation >
Contact info
Phone: 08-750 00 00
Website:
https://www.intertek.se
Postal address
Intertek Semko AB
Box 1103
164 22 Kista
Accreditation fields
Notification, Notified body, SS-EN ISO/IEC 17021-1:2015
Notified body (17021) |
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Regulation
| Title | Name |
|---|---|
| (EU) nr 920/2013 | medical devices |
| 93/42/EEG | Medical devices (MDD) |
| LVFS 2003:11 | |
| STAFS 2020:1 | Swedac´s Regulations and General Guidelines on Accreditation |
| STAFS 2022:7 |
Notification, Notified body, SS-EN ISO/IEC 17065:2012
Notified Body (17065) |
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Regulation
| Title | Name |
|---|---|
| 2014/30/EU | Electromagnetic Compatibility (EMC) |
| 2014/53/EU | Radio equipment (RED) |
| ELSÄK-FS 2016:3 | The Swedish Electrical Safety Board's regulations on electromagnetic compatibility |
| PTSFS 2016:5 | |
| STAFS 2020:1 | Swedac´s Regulations and General Guidelines on Accreditation |
| STAFS 2022:7 |
Accreditation scope
- A000426-002 Ackr omfattning 191119 MDD ENG.pdf
- A000426-002 Ackr omfattning 191119 MDD.pdf
- A000426-002 Omfattning Anmält organ, 2014_53_EU RED, 1003, 240523.pdf
- A000426-002 Omfattning Anmält organ, EMC 17065, 220908.pdf
- A000426-002 Scope Notified Body, 2014_53_EU RED, 1003, 240523.pdf
- A000426-002 Scope Notified Body, EMC 17065, 220908.pdf