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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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 19 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
3,7-dimethylocta-2,6-dienenitrile
225-918-0
5146-66-7
Muta. 1B
3,7-dimethyloctanenitrile
HYPO-LEM
403-620-3
40188-41-8
Skin Irrit. 2; Skin Sens. 1
3,9-bis(2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy-1,1-dimethylethyl)-2,4,8,10-tetraoxaspiro[5.5]undecane
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
3-((2-nitro-4-(trifluoromethyl)phenyl)amino)propane-1,2-diol
FLUORGELB
410-010-0
104333-00-8
Acute Tox. 4
3-((4-(bis(2-hydroxyethyl)amino)-2-nitrophenyl)amino)-1-propanol
IMEXINE FAG
410-910-3
104226-19-9
Skin Sens. 1
3-((C12-18)-acylamino)-N-(2-((2-hydroxyethyl)amino)-2-oxoethyl)-N,N-dimethyl-1-propanaminium chloride
427-370-1
164288-56-6
Eye Dam. 1
3-(2'-phenoxyethoxy)propylamine
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
BLUE PE 3811
424-310-4
178452-66-9
Eye Dam. 1
3-(2-(diaminomethyleneamino)thiazol-4-ylmethylthio)propionitrile
TPN
403-710-2
76823-93-3
Acute Tox. 4; Skin Sens. 1
3-(2-bromopropionoyl)-4,4-dimethyl-1,3-oxazolan-2-one
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
3-(2-chloroethyl)-6,7,8,9-tetra-hydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one monohydrochloride
424-530-0
93076-03-0
Acute Tox. 3; STOT SE 2; STOT RE 2; Eye Dam. 1; Skin Sens. 1
3-(2-ethylhexyloxy)propane-1,2-diol
2-EHOPD; EHOPD; GE-EH; SENSIVA SC 50
408-080-2
70445-33-9
Eye Dam. 1
3-(2H-tetrazol-5-yl)pyridine
5-(3-PYRIDYL)-TETRAZOL
426-810-8
3250-74-6
Eye Dam. 1
3-(3-amino-5-(1-methylguanidino)-1-oxopentylamino-6-(4-amino-2-oxo-2,3-dihydro-pyrimidin-1-yl)-2,3-dihydro-(6H)-pyran-2-carboxylic acid; blasticidin-s
606-640-2
2079-00-7
Acute Tox. 2
3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin; difenacoum
259-978-4
56073-07-5
Repr. 1B; Acute Tox. 1; STOT RE 1
3-(3-methylpent-3-yl)isoxazol-5- ylamine
128719
401-460-9
82560-06-3
Acute Tox. 3; Eye Dam. 1
3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
G 19-675 ZP
403-920-4
107551-67-7
Acute Tox. 4; Eye Irrit. 2
3-(4-aminophenyl)-2-cyano-2-propenoic acid
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
3-(4-chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
3-(4-fluorophenyl)-2-methylpropionylchloride
426-370-7
1017183-70-8
Skin Corr. 1A; Acute Tox. 4
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
257-187-9
51414-25-6
Skin Sens. 1A
3-(6-O-(6-desoxy-α-l-mannopyranosyl-O-(α-d-glucopyranosyl)-(β-d-glucopyranosyl)oxy)-2-(3,4-dihydroxyphenyl)-5,7-dihydroxy-4H-1-benzopyran-4-one
424-170-4
130603-71-3
Skin Sens. 1
3-(benzo[b]thien-2-yl)-5,6-dihydro-1,4,2-oxathiazine-4-oxide
431-030-6
163269-30-5
Acute Tox. 3; STOT RE 2; Eye Dam. 1
3-(bis(2-ethylhexyl)amino methyl)benzothiazole-2(3H)- thione
CM 22-447
402-540-6
105254-85-1
Skin Corr. 1B; Skin Sens. 1
3-(cis-1-propenyl)-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
7-PACA
415-750-8
106447-44-3
Skin Sens. 1
3-(cis-3-hexenyloxy)propanenitril
PARMANYL
415-220-6
142653-61-0
Acute Tox. 3; Acute Tox. 4
3-(difluoromethyl)-1-methyl-N-(3',4',5'-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide; fluxapyroxad
620-041-3
907204-31-3
Lact.
3-(dimethylamino)propylurea
3-(DIMETHYLAMINO)PROPYL UREA; HST 2844
401-950-2
31506-43-1
Eye Dam. 1
3-(hydroxyphenylphosphinyl)propanoic acid
FYROL 3-HPP; HIRETAR-205; PHOSGARD PF 100
411-200-6
14657-64-8
Eye Dam. 1
3-(N-methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol hydrochloride
IMEXINE FAE
403-440-5
93633-79-5
Acute Tox. 4
3-(piperazin-1-yl)-benzo[d]isothiazole hydrochloride
421-310-6
87691-88-1
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
3-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-(E)-2-propenal
425-370-4
93957-50-7
Skin Sens. 1
3-acetyl-1-phenyl-pyrrolidine-2,4-dione
ADDITIVE F6
421-600-2
719-86-8
STOT RE 2
3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione; dehydracetic acid
208-293-9
520-45-6
Acute Tox. 4
3-amino-4-hydroxy-N-(2-methoxyethyl)-benzenesulfonamide
FAT 92.346 B
411-520-6
112195-27-4
Eye Dam. 1; Skin Sens. 1
3-amino-4-hydroxy-N-(3-isopropoxypropyl)benzenesulfonamide hydrochloride
427-780-9
114565-70-7
Acute Tox. 4; Eye Dam. 1
3-amino-9-ethyl carbazole; 9-ethylcarbazol-3-ylamine
205-057-7
132-32-1
Carc. 1B
3-aminobenzene sulphonic acid; metanilic acid
204-473-6
121-47-1
Acute Tox. 4
3-aminobenzylamine
SUBSTANCE S68494
412-230-2
4403-70-7
Acute Tox. 4; Skin Corr. 1B
3-aminomethyl-3,5,5-trimethylcyclohexylamine
220-666-8
2855-13-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-aminophenol
209-711-2
591-27-5
Acute Tox. 4
3-aminopropyldiethylamine; N,N-diethyl-1,3-diaminopropane
203-236-4
104-78-9
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-aminopropyldimethylamine; N,N-dimethyl-1,3-diaminopropane
203-680-9
109-55-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-aminopropyltriethoxysilane
213-048-4
919-30-2
Acute Tox. 4; Skin Corr. 1B
3-azidosulfonylbenzoic acid
ASB
405-310-3
15980-11-7
Self-react. C; STOT RE 2; Eye Dam. 1; Skin Sens. 1
3-benzyl-exo-6-nitro-2,4-dioxo-3-aza-cis-bicyclo[3.1.0]hexane
426-750-2
151860-15-0
Skin Sens. 1
3-butoxypropan-2-ol; propylene glycol monobutyl ether
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
3-chloro-2,4-difluoronitrobenzene
3-CHLORO-2,4-DIFLUORONITROBENZENE
411-980-8
3847-58-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3-chloro-2-(isopropylthio)aniline
CA 2272 A
421-700-6
179104-32-6
Skin Irrit. 2
3-chloro-2-methylpropene
209-251-2
563-47-3
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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