EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

Last updated 28 svibnja 2024. Database contains 4917 unique substances/entries.
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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Acute Tox. 4
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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DESBIMID
401-970-1
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Skin Sens. 1
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Muta. 2; Repr. 1B
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473-390-7
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VPVB very Persistent and very Bioaccumulative (article 57e)
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KAYARAD R-825
405-360-6
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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ADINE CP 31
401-740-0
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Acute Tox. 4
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915-270-3
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R Toxic for reproduction (article 57c)
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Repr. 1B
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Repr. 1B
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PK 323
401-940-8
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Acute Tox. 4; Eye Irrit. 2
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X 3761
400-930-0
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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SUBSTANCE S166075
424-270-8
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Eye Dam. 1
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UNISOL S
405-760-0
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Eye Dam. 1; Skin Sens. 1
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EMULGATOR SWA; EMULVIN SWA
406-325-8
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Acute Tox. 4
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430-200-7
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Eye Dam. 1
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ETHOXYLATED POLYESTER RESIN
405-960-8
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Skin Sens. 1
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LOVASTATIN FREE ACID
415-840-7
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Skin Sens. 1
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442-480-8
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Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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433-640-8
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Pyr. Sol. 1
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427-040-5
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Skin Corr. 1B
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426-530-6
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Skin Irrit. 2
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GA1270; HOE S 4096
407-290-1
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Eye Dam. 1
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434-330-5
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Carc. 2; Skin Sens. 1
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Z-19
414-520-4
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Skin Irrit. 2; Eye Dam. 1
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429-710-2
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Self-react. D; Acute Tox. 4
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442-300-8
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Skin Sens. 1
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429-590-1
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Skin Sens. 1
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F1 MINERAL FLOTATION COLLECTOR (40% HTEA.HCL)
405-720-2
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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RED E190
411-560-4
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STOT RE 1; Skin Sens. 1
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428-050-2
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Skin Sens. 1
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SPE 93279
414-420-0
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Eye Dam. 1
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419-000-0
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Skin Sens. 1
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EUGEWHITE
412-020-0
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Skin Sens. 1
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MMA-10R
423-670-1
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Eye Dam. 1; Skin Sens. 1
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442-800-6
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Skin Irrit. 2
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ROT Y; RUBINOT Y; RUBINROT Y
408-240-1
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Acute Tox. 4
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440-510-4
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Eye Dam. 1; Skin Sens. 1
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435-440-6
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Eye Dam. 1
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431-440-5
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Eye Dam. 1
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FORMYLTRICYCLODECEN, EXO
410-480-7
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Skin Sens. 1
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423-750-4
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Eye Irrit. 2
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R 7623 TECHNICAL
403-250-2
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Carc. 2; Repr. 1B; Acute Tox. 4
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T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
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STOT RE 2
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