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 16 rujna 2024. Database contains 4917 unique substances/entries.
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427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
215-648-1
1336-36-3
STOT RE 2
Details
618-541-1
9036-19-5
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
Details
608-042-7
27083-27-8
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
Details
PAA HCL; PAA HCL 10L; PAA HCL 10S; PAA HCL 3L; PAA HCL 3S; PAA HCL H; PAA HCL L
415-050-2
71550-12-4
Acute Tox. 4; Skin Sens. 1
Details
X4060
404-035-6
1379801-27-0
Skin Sens. 1
Details
-
299-45-6
Acute Tox. 2; Acute Tox. 1
Details
231-119-8
7440-09-7
Water-react. 1; Skin Corr. 1B
Details
246-376-1
24634-61-5
Eye Irrit. 2
Details
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
Details
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
Details
418-260-2
183196-57-8
Skin Sens. 1
Details
266-578-3
67118-55-2
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
Details
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
Details
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
Details
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
Details
233-002-7
10007-85-9
Eye Irrit. 2
Details
426-300-5
-
Eye Dam. 1
Details
V67282
406-500-9
174393-75-0
Skin Sens. 1
Details
426-620-5
619297-89-1
Eye Dam. 1
Details
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
Details
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
Details
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
Details
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 3
Details
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
Details
209-676-3
590-28-3
Acute Tox. 4
Details
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
Details
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
Details
232-151-5
7789-23-3
Acute Tox. 3
Details
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
Details
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A
Details
-
-
C Carcinogenic (article 57a)
Details
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
Details
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
Details
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
Details
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
Details
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
Details
231-832-4
7758-09-0
Ox. Sol. 2; Acute Tox. 3
Details
231-911-3
7778-73-6
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
231-912-9
7778-74-7
Ox. Sol. 1; Acute Tox. 4
Details
701-468-5
21049-36-5
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
223-393-2
3871-99-6
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
220-527-1
2795-39-3
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
Details
231-760-3
7722-64-7
Ox. Sol. 2; Repr. 2; Acute Tox. 4
Details
253-390-1
37199-66-9
Skin Corr. 1B
Details

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