EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This 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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

Last updated 19 April 2024. Database contains 4753 unique substances/entries.
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430-050-2
-
Skin Sens. 1
414-340-6
-
Flam. Liq. 3; Acute Tox. 4; STOT SE 2; Eye Dam. 1; Skin Sens. 1
PERGASCRIPT BLACK 20223 AMIDE INTERMEDIATE
420-600-1
-
STOT RE 2
VERNETZER TMAG
412-790-8
-
Carc. 1B; Muta. 2; STOT RE 2
COMPLEXING AGENT BN
410-650-0
-
Eye Dam. 1; Skin Sens. 1
423-580-0
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STOT RE 2
423-010-0
-
Eye Dam. 1
444-290-0
508202-43-5
Eye Dam. 1; Skin Sens. 1
450-010-8
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Eye Dam. 1; Skin Sens. 1
432-100-9
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Eye Dam. 1
445-280-9
371921-40-3
Eye Dam. 1; Skin Sens. 1
MARINE REN 600
424-320-9
180778-23-8
Eye Dam. 1
COLUMBIADUNKELBLAU R
415-350-3
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Eye Dam. 1
422-500-1
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STOT RE 2
433-860-4
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Eye Irrit. 2; Skin Sens. 1
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
EVAPORATED ELEMINOL JS-2 MATERIAL
410-230-7
-
Skin Corr. 1B; Skin Sens. 1
TASP
411-250-9
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Skin Sens. 1
426-470-0
214897-29-7
Skin Sens. 1
427-740-0
-
Eye Dam. 1; Skin Sens. 1
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 1
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
-
Skin Sens. 1
ACID RED HT 3728; ERIONYL RED HT 3728
410-070-8
141880-36-6
Skin Sens. 1
432-790-1
847871-03-8
Acute Tox. 4; Skin Corr. 1B; STOT SE 2
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PRICARE
411-910-6
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-440-5
-
Eye Dam. 1
PROCION YELLOW PX-R; S154357; SUBSTANCE S154357
412-940-2
148878-18-6
Skin Sens. 1
ITC 288/S
410-800-5
-
Skin Sens. 1
EBO
417-540-1
-
Eye Dam. 1
BDS-HEXAFLUOROPHOSPHATE; BDS-HEXAFLUORPHOSPHAT; ESACURE 1004
404-986-7
74227-35-3
Eye Dam. 1
CYRACURE PHOTOINITIATOR UVI-6990; CYRACURE PHOTOINITIATOR UVI-6992
403-490-8
104558-95-4
Eye Irrit. 2; Skin Sens. 1
ACETOXYACID
411-660-8
147027-04-1
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2-ISOPROPYL-5-CARBOXY-1,3-DIOXANE
418-170-3
116193-72-7
Eye Dam. 1
CLARYCET
412-450-9
131766-73-9
Skin Sens. 1
429-620-3
110028-14-3
Skin Irrit. 2; Skin Sens. 1
432-230-6
-
STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
438-310-7
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Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
ARQUAD 3.16
405-620-9
-
Eye Dam. 1
DUASYN DIREKTSCHWARZ HEF-SF VP 332
411-890-9
108936-08-9
Acute Tox. 4; Eye Dam. 1
C.I. DIRECT BLACK 184; C.I. DIRECT NOIR 184
406-000-0
173939-66-7
Eye Dam. 1
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
428-260-4
-
Eye Dam. 1
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
428-400-4
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Eye Dam. 1
444-050-5
-
Eye Dam. 1
RED MDO 358
414-620-8
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Eye Dam. 1; Skin Sens. 1
NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
402-850-1
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Eye Dam. 1
P2-800; P2-935LV
415-870-0
-
Skin Sens. 1
GA161895; GLUCAMIDE
411-130-6
-
Eye Dam. 1

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