EU-MEDICAL_DEVICES-ANX_I_7_8

Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Directive 93/42/EEC, 12 July 1993, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

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Last updated 18 April 2024. Database contains 4753 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
2-ethoxyethanol; ethylene glycol monoethyl ether
203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
2-ethoxyethyl 2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate
C.I. DISPERSE RED 367
403-960-2
147014-52-6
Skin Sens. 1
2-ethoxyethyl acetate; ethylglycol acetate
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
2-ethyl-2,3-dihydro-2-methyl-1H-perimidine
424-380-6
43057-68-7
Acute Tox. 4; STOT RE 2
2-ethyl-N-methyl-N-(3-methylphenyl)butanamide
PARADISAMIDE
446-190-2
406488-30-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-ethylbutan-1-ol
202-621-4
97-95-0
Acute Tox. 4
2-ethylhexane-1,3-diol; octylene glycol; ethoexadiol
202-377-9
94-96-2
Eye Dam. 1
2-ethylhexanoato-O)(neodecanoato-O)nickel
285-698-7
85135-77-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
2-ethylhexanoic acid
205-743-6
149-57-5
Repr. 2
2-ethylhexanoic acid, nickel salt
231-480-1
7580-31-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
260-829-0
57583-35-4
Repr. 2; Acute Tox. 4; STOT RE 1; Skin Sens. 1A
2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; [DOTE]
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
260-828-5
57583-34-3
Repr. 2
2-ethylhexyl acrylate
203-080-7
103-11-7
STOT SE 3; Skin Irrit. 2; Skin Sens. 1
2-ethylhexyl-2-ethylhexanoate
231-057-1
7425-14-1
Repr. 2
2-ethylhexyl[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]thio]acetate
279-452-8
80387-97-9
Repr. 1B; Skin Sens. 1
2-ethylphenylhydrazine hydrochloride
2-EPH
421-460-2
19398-06-2
Carc. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-fluoro-4-hydroxybenzonitrile
2-FLUOR-4-HYDROXYBENZONITRIL
422-810-7
82380-18-5
Acute Tox. 4; Eye Dam. 1
2-fluoro-5-trifluoromethylpyridine
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
2-fluoro-6-trifluoromethylpyridine
428-100-3
94239-04-0
Flam. Liq. 3; Acute Tox. 4
2-fluoroacetamide
211-363-1
640-19-7
Acute Tox. 2; Acute Tox. 3
2-furaldehyde
202-627-7
98-01-1
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2-hexyloxyethanol; ethylene glycol monohexyl ether; n-hexylglycol
203-951-1
112-25-4
Acute Tox. 4; Skin Corr. 1B
2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one
444-860-9
474510-57-1
STOT RE 2
2-hydroxy-1-methylethylacrylate
220-852-9
2918-23-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2-hydroxy-2-methylpropionitrile; 2-cyanopropan-2-ol; acetone cyanohydrin
200-909-4
75-86-5
Acute Tox. 2; Acute Tox. 1
2-hydroxy-3-(2-ethyl-4-methylimidazoyl)propyl neodecanoate
EPIKURE DX 6906
417-350-9
776326-15-9
Skin Irrit. 2; Eye Dam. 1
2-hydroxy-3-[(2-hydroxyethyl)-[2-(1-oxotetradecyl)amino]ethyl]amino]-N,N,N-trimethyl-1-propanammonium chloride
AMINO CATION S-36
414-670-0
141890-30-4
Acute Tox. 4; Eye Dam. 1
2-hydroxyethyl acrylate
212-454-9
818-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2-hydroxyethyl methacrylate
212-782-2
868-77-9
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-hydroxyethylammonium perbromide
LIQUIBROM 2038
407-440-6
127395-77-1
Ox. Sol. 2; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
2-hydroxymethyl-9-methyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decane
FRESCOLAT MGA
408-200-3
63187-91-7
Skin Irrit. 2; Eye Dam. 1
2-hydroxypropyl methacrylate
213-090-3
923-26-2
Eye Irrit. 2; Skin Sens. 1
2-hydroxypropylacrylate
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2-isobutyl-2-isopropyl-1,3-dimethoxypropane
430-800-9
129228-21-3
Skin Irrit. 2
2-isopropoxyethanol; ethylene glycol monoisopropyl ether
203-685-6
109-59-1
Acute Tox. 4; Eye Irrit. 2
2-isopropyl-2-(1-methylbutyl)-1,3-dimethoxypropane
406-970-5
129228-11-1
Skin Irrit. 2
2-isopropyl-4-(N-methyl)aminomethylthiazole
A-87463.0
414-800-6
154212-60-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-isopropyl-5-methylcyclohexyloxycarbonyloxy-2-hydroxypropane
FRESCOLAT MPC
417-420-9
156324-82-2
Eye Irrit. 2
2-methoxy-1-methylethyl acetate
203-603-9
108-65-6
Flam. Liq. 3
2-methoxy-2-methylbutane; tert-amyl methyl ether
213-611-4
994-05-8
Flam. Liq. 2; Acute Tox. 4; STOT SE 3
2-methoxyaniline; o-anisidine
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
2-methoxyethanol; ethylene glycol monomethyl ether
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
2-methoxyethyl acetate; methylglycol acetate
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
2-methoxyethyl acrylate
221-499-3
3121-61-7
Flam. Liq. 3; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1
2-methoxyethylmercury chloride
204-659-7
123-88-6
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-methoxypropanol
216-455-5
1589-47-5
Flam. Liq. 3; Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
2-methoxypropyl acetate
274-724-2
70657-70-4
Flam. Liq. 3; Repr. 1B; STOT SE 3
2-methyl-1,2-benzothiazol-3(2H)-one; [MBIT]
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
2-methyl-1,5-pentanediamine-1,3-benzenedicarboxylate
433-910-5
145153-52-2
Skin Sens. 1
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