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 24 lipnja 2024. Database contains 4917 unique substances/entries.
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421-560-6
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STOT RE 2; Eye Dam. 1
Details
216-823-5
1675-54-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
TK 10891; XB 4458; XW 528; ZK XB 4458
405-635-0
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Skin Irrit. 2; Eye Dam. 1
Details
VECTOMER E2200
413-930-0
130066-57-8
Skin Sens. 1
Details
TITANCHELAT ETAM
410-500-4
357921-97-2
Eye Dam. 1
Details
MCP-304
415-210-1
160236-81-7
Acute Tox. 4; Eye Dam. 1
Details
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
R Toxic for reproduction (article 57c)
END Endocrine disrupting properties (Article 57(f) - human health)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
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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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F Fungi
Details
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90568-23-3
R Toxic for reproduction (article 57c)
Details
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125022-34-6
R Toxic for reproduction (article 57c)
Details
616-932-1
8011-63-0
Acute Tox. 4; Eye Dam. 1
Details
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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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234-343-4
11113-50-1
Repr. 1B
R Toxic for reproduction (article 57c)
Details
233-139-2
10043-35-3
Repr. 1B
R Toxic for reproduction (article 57c)
Details
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22454-04-2
R Toxic for reproduction (article 57c)
Details
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14890-53-0
R Toxic for reproduction (article 57c)
Details
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25747-83-5
R Toxic for reproduction (article 57c)
Details
215-604-1
1333-73-9
R Toxic for reproduction (article 57c)
Details
233-657-9
10294-33-4
Acute Tox. 2; Skin Corr. 1A
Details
233-658-4
10294-34-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
Details
231-569-5
7637-07-2
Press. Gas; Acute Tox. 2; Skin Corr. 1A
Details
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B Bacteria and similar species
Details

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