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 14 listopada 2024. Database contains 4918 unique substances/entries.
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203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
Details
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
Details
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
Details
429-570-2
213990-58-0
Skin Sens. 1
Details
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
Details
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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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7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
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29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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B Bacteria and similar species
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203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
Details
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
Details
205-628-0
144-41-2
Acute Tox. 3
Details
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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.
Details
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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.
Details
248-505-7
27519-02-4
Skin Sens. 1B
Details
201-328-9
81-14-1
Carc. 2
Details
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
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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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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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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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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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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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435-860-1
214417-91-1
Skin Sens. 1
Details
429-380-1
133336-92-2
Skin Sens. 1
Details
430-930-6
122886-55-9
Eye Dam. 1; Resp. Sens. 1
Details
435-010-8
26157-73-3
Muta. 2
Details
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
Details
BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
Details
200-806-4
74-31-7
Skin Sens. 1
Details
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1
Details
CARTASOL BRILLIANT YELLOW K-6G; CARTASOL BRILLIANT YELLOW K-6G CONC.; GIALLO BRILLANTE CARTASOL K-6G CONC.; JAUNE BRILLANT CARTASOL K-RWA 3904; RWA 3904
403-340-1
164578-09-0
Eye Dam. 1
Details
202-831-6
100-22-1
Acute Tox. 4
Details
AF-172; FPC 114
405-300-9
17339-60-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
Details

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