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 06 rujna 2024. Database contains 4917 unique substances/entries.
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Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Azadirachta indica, Meliaceae.
283-644-7
84696-25-3
Repr. 2; Skin Sens. 1
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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P Parasites
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P Parasites
Details
239-924-6
15825-70-4
Expl. 1.1
Details
239-924-6
15825-70-4
Unst. Expl.
Details
232-089-9
7785-87-7
STOT RE 2
Details
215-202-6
1313-13-9
Acute Tox. 4
Details
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
Details
203-703-2
109-77-3
Acute Tox. 3
Details
203-571-6
108-31-6
Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1A
Details
203-742-5
110-16-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
204-497-7
121-75-5
Acute Tox. 4; Skin Sens. 1
Details
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
Details
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
Details
BLACK JR 578
419-230-1
-
Skin Sens. 1
Details
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
Details
422-610-1
-
Eye Dam. 1
Details
442-650-1
56450-90-9
STOT RE 2
Details
231-104-6
7439-95-4
Water-react. 1; Pyr. Sol. 1
Details
231-104-6
7439-95-4
Flam. Sol. 1; Water-react. 2; Self-heat. 1
Details
235-023-7
12057-74-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
Details
241-022-2
16949-65-8
Acute Tox. 3
Details
DUPLOSAN-DP-MAGNESIUM
413-360-2
164058-21-3
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details

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