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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 12 April 2024. Database contains 4753 unique substances/entries.
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KENODOX
404-300-6
116753-76-5
Org. Perox. C
ETA; ETA 50 (50 %IGE ZUBEREITUNG); O-ETHYLHYDROXYLAMINE
402-030-3
624-86-2
Flam. Liq. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Sens. 1
432-750-3
109202-58-6
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
434-350-4
103122-66-3
Flam. Liq. 3; Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
PROCION BRILLIANT ORANGE H-EXL; S156745
412-960-1
148878-21-1
Eye Dam. 1; Skin Sens. 1
H112339
413-550-5
-
Skin Irrit. 2; Eye Dam. 1
DAISO CCS-1S-E; S-GLYTO
417-210-7
70987-78-9
Carc. 1B; Muta. 2; Eye Dam. 1; Skin Sens. 1
LUCHEM HA-R 100; LUPERSOL HA-R 100
413-230-5
122035-71-6
Eye Dam. 1; Skin Sens. 1
UP 565
411-530-0
15024-10-9
Skin Sens. 1
426-590-3
187412-41-5
Skin Sens. 1
404-290-3
7216-95-7
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
418-270-7
-
Skin Sens. 1
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
436-920-8
172399-10-9
Eye Dam. 1
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
414-910-4
-
Eye Dam. 1; Skin Sens. 1
442-030-0
321912-47-4
Eye Dam. 1
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
DPX-E6758
406-600-2
89392-03-0
Skin Sens. 1
432-400-1
10102-09-7
Skin Corr. 1A
AOC 2050X
403-430-0
138360-92-6
Eye Dam. 1
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
RX-33
419-590-1
-
Flam. Sol. 1; Skin Sens. 1
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
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
X4060
404-035-6
1379801-27-0
Skin Sens. 1
418-260-2
183196-57-8
Skin Sens. 1
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
426-300-5
-
Eye Dam. 1
V67282
406-500-9
174393-75-0
Skin Sens. 1
426-620-5
619297-89-1
Eye Dam. 1
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4
D(-) VALINE DANE SALT
427-240-2
134841-35-3
Skin Sens. 1
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
POTASSIUM-P-TOLYLSULFIMIDE
406-650-5
97888-41-0
Eye Dam. 1
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1
REAKTIVROT 2713
412-490-7
-
Skin Sens. 1
C.I. REACTIVE RED 231
402-150-6
-
Eye Irrit. 2; Skin Sens. 1
SUMIFIX BRILLIANTBLAU GL KONZENTRAT
414-100-0
154336-20-6
Eye Dam. 1
425-830-4
-
Eye Dam. 1
432-240-0
12056-51-8
Carc. 2

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