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 15 travnja 2024. Database contains 4917 unique substances/entries.
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600-611-8
10486-00-7
R Toxic for reproduction (article 57c)
Details
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
603-902-8
13517-20-9
R Toxic for reproduction (article 57c)
Details
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
Details
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
201-186-8
79-21-0
Flam. Liq. 3; Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
Details
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B Bacteria and similar species
Details
232-629-3
9001-75-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
210-852-7
624-54-4
Flam. Liq. 3
Details
207-332-7
463-04-7
Flam. Liq. 2; Acute Tox. 4
Details
211-340-6
638-49-3
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
Details
211-047-3
628-63-7
Flam. Liq. 3
Details
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
256-418-0
49663-84-5
C Carcinogenic (article 57a)
Details
442-030-0
321912-47-4
Eye Dam. 1
Details
414-910-4
-
Eye Dam. 1; Skin Sens. 1
Details
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
Details
436-920-8
172399-10-9
Eye Dam. 1
Details
301-312-2
93983-23-4
Eye Irrit. 2
Details
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
Details
205-391-3
140-01-2
Repr. 1B; Acute Tox. 4; STOT RE 2
Details
418-270-7
-
Skin Sens. 1
Details
404-290-3
7216-95-7
Repr. 1B; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
Details
250-378-8
30899-19-5
Flam. Liq. 3; Acute Tox. 4; STOT SE 3
Details
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
Details
203-692-4
109-66-0
Flam. Liq. 2; Asp. Tox. 1; STOT SE 3
Details
202-490-3
96-22-0
Flam. Liq. 2; STOT SE 3
Details
235-067-7
12065-90-6
R Toxic for reproduction (article 57c)
Details
426-590-3
187412-41-5
Skin Sens. 1
Details
222-540-8
3524-68-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
201-084-3
78-11-5
Expl. 1.1
Details
201-084-3
78-11-5
Unst. Expl.
Details
225-644-1
4986-89-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
276-745-2
72629-94-8
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
201-778-6
87-86-5
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
200-925-1
76-01-7
Carc. 2; STOT RE 1
Details
210-172-0
608-93-5
Flam. Sol. 1; Acute Tox. 4
Details
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F Fungi
Details
254-938-2
40487-42-1
Repr. 2
Details
266-275-6
66246-88-6
Repr. 2; Acute Tox. 4
Details
214-215-4
1114-71-2
Acute Tox. 4
Details
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B Bacteria and similar species
Details
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B Bacteria and similar species
Details
206-050-1
298-00-0
Flam. Liq. 3; Acute Tox. 2; Acute Tox. 3; STOT RE 2
Details
200-271-7
56-38-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1
Details
218-196-3
2074-50-2
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
217-615-7
1910-42-5
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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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P Parasites
Details
307-202-0
97553-43-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details

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