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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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426-530-6
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Skin Irrit. 2
GA1270; HOE S 4096
407-290-1
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Eye Dam. 1
434-330-5
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Carc. 2; Skin Sens. 1
Z-19
414-520-4
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Skin Irrit. 2; Eye Dam. 1
429-710-2
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Self-react. D; Acute Tox. 4
442-300-8
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Skin Sens. 1
429-590-1
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Skin Sens. 1
PIGMENTADDITIV P
411-310-4
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Eye Dam. 1
F1 MINERAL FLOTATION COLLECTOR (40% HTEA.HCL)
405-720-2
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
RED E190
411-560-4
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STOT RE 1; Skin Sens. 1
428-050-2
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Skin Sens. 1
SPE 93279
414-420-0
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Eye Dam. 1
419-000-0
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Skin Sens. 1
EUGEWHITE
412-020-0
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Skin Sens. 1
MMA-10R
423-670-1
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Eye Dam. 1; Skin Sens. 1
442-800-6
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Skin Irrit. 2
ACRYLSKUM; T-2816 FOAMER
407-810-7
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STOT RE 2
ROT Y; RUBINOT Y; RUBINROT Y
408-240-1
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Acute Tox. 4
440-510-4
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Eye Dam. 1; Skin Sens. 1
435-440-6
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Eye Dam. 1
DISPERSIONSROT 2754
411-880-4
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Skin Sens. 1
431-440-5
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Eye Dam. 1
FORMYLTRICYCLODECEN, EXO
410-480-7
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Skin Sens. 1
34 DIAZO
417-080-1
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Self-react. D; Skin Sens. 1
423-750-4
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Eye Irrit. 2
R 7623 TECHNICAL
403-250-2
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Carc. 2; Repr. 1B; Acute Tox. 4
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
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Muta. 2; Skin Sens. 1
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
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STOT RE 2
INTERMEDIAIRE AR HT 3728
410-065-0
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Skin Sens. 1
DP 15
410-640-6
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Skin Irrit. 2; Eye Dam. 1
AMMONIUM DIAS
407-320-3
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Skin Irrit. 2; Eye Dam. 1
A-88820.605
414-810-0
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STOT RE 2; Eye Dam. 1
MCP 455
406-240-6
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Flam. Liq. 3; Skin Corr. 1B
MDI
406-550-1
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Skin Sens. 1
422-920-5
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STOT RE 2
SP 7053
415-930-6
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Repr. 2; Skin Sens. 1
SP 7077
430-180-1
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Skin Irrit. 2
429-990-6
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Eye Dam. 1; Skin Sens. 1
NEWLON AM-92I
407-490-9
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Acute Tox. 4; Skin Corr. 1B
OLOA 224 (OIL FREE)
420-470-4
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Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
427-140-9
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Carc. 2
435-960-3
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Carc. 1B; Muta. 1B; Skin Sens. 1
DYE K
402-660-9
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Repr. 1B
426-840-1
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Eye Dam. 1
PRICARE
411-860-5
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Skin Sens. 1
434-420-4
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Skin Irrit. 2; Eye Dam. 1
CYANEX (R) EXTRACTANT; CYANEX 923 EXTRACTANT
403-470-9
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Skin Corr. 1B
434-240-6
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Skin Sens. 1
REACTIVE YELLOW FC 75560
419-450-8
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Skin Sens. 1
430-050-2
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Skin Sens. 1

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