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Contents
1. EMEA European Agency for the Evaluation of Medical Products MDD Annex 4 32. a b c EMDS d EMDS EMDS European Diagnostic Market Statistics Nomenclature http www edma ivd be HIVDD A HIVDD B IIVDD TUV Product Service IVDD Annex V IVDD Annex IV 4 IVDD Annex 6 IVDD AnnexVI AnnexT A B 2 _IVDD AnnexIV AnnexT An gt TUV Product Service
3. TUV Product Service AIMDD Annex 2 4 Annex 2 3 AIMDD Annex 3 Annex 5 AIMDD Annex 3 Annex 4 EC AIMDD Annex 3 5 3 4 Annex 3 AIMDD Annex 3 vp 0 0 E mail Teephnone 181 3 3372 4821 MED_F_03 06J
4. IVDD Annex IV IVDD Annex VI E mail Telepnone 81 3 337 4821 MED_F 03 06J docx Telefax 181 3 3372 4163 Rev 9 ItH Wwwuhuvsucljp 160 0023 2009 09 01 4334 Page 74 TUV 4 8F EN ISO 13485 AIMD MDD IVDD gt 5 Hn
5. 1 1 MED_F_03 06J docx Rev 9 2009 09 01 Page 34 EN ISO 13485 ISO13485 CMDCAS ISO9001 2008 EN ISO 13485 ISO13485 CMDCAS ISO9001 2008 EN ISO 13485 ISO13485 CMDCAS ISO9001 2008 Telepnone 81 3 3372 4821 Telefex 81 3 3 4163 ItH Wwwuhuv
6. 1 EN ISO13485 ISO9001 1 2 AIMDD 90 385 EEC 1 3 MDD 93 42 EEC 2 4 IVDD 98 79 EEC 1 5 2000 70 EEC 1 2003 32 EEC Telepnone 181 3 3372 4821 MED_F 03 06J docx Telefax 81 3 33 4163 Rev 9 Httpx WwwutuySucljp 160 0023 2009 09 01 4334 Page 24 TUV 4 8F EN ISO 13485 AIMD MDD IVDD gt 1 US QSR s
7. Teephone 181333 4821 MED_F 03 06J docx Telefax 81 3 33 4163 Rev 9 Httpx WwwutuySucljp 160 0023 2009 09 01 4334 Page 84 TUV 4 8F
8. Teephone 181333 4821 MED_F 03 06J docx Telefax 81 3 33 4163 Rev 9 Httpx WwwutuySucljp 160 0023 2009 09 01 4334 Page 54 TUV 4 8F EN ISO 13485 AIMD MDD IVDD gt E mail Teephnone 181 3 3372 4821 MED_F_03 06J docx Taefex 81 3 337 4163 Rev 9 ItH Wwwuhuvsucljp 160 0023 2009 09 01 433 4 Page 6 TUV 4 8F EN ISO 13485 AIMD MDD IVDD gt 4 IVDD
9. EN ISO 13485 AIMD MDD IVDD gt Japan 1 E mail HP Xx ET Teephone 181333 4821 MED_F 03 06J docx Telefax 81 3 33 4163 Rev 9 Httpx WwwutuySucljp
10. TUV Product Service MDD Annex MDD Annex I 4 IIb TUV Product Service MDD Annex I MDD Annex IV EC MDD Annex V MDD AnnexVI I Annex V 1 AnnexY V Y MDD Annex V IY VI Annex AnnexLL
11. 160 0023 2009 09 01 4334 Page 14 TUV 4 8F EN ISO 13485 AIMD MDD IVDD gt ISO9000 AIDMMDD IVDD FE EE 1 em OEM
12. docx Taefex 81 3 337 4163 Rev 9 ItH Wwwuhuvsucljp 160 0023 2009 09 01 433 4 Page 4 TUV 4 8F EN ISO 13485 AIMD MDD IVDD gt 3 MDD a b c UMDNS GMDN d UMDNS GMDN UMDNS Universal Medical Device Nomenclature System GMDN Global Medical Device Nomenclature http gmdn org MDD 1 MDD 1 MDD Ia MDD Ib MDD MDD Annex
13. sucljp 160 0023 4334 TUV 4 8F EN ISO 13485 AIMD MDD IVDD gt 2 AIMDD a b c UMDNS GMDN d UMDNS GMDN UMDNS Universal Medical Device Nomenclature System GMDN Global Medical Device Nomenclature http gmdn org TUV Product Service AIMDD Annex 3 AIMDD Annex 2 4
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