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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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.

Last updated 23 april 2024. Database contains 4753 unique substances/entries.
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NAVY DER 7850
417-640-5
161935-19-9
Eye Dam. 1; Skin Sens. 1
NITROBLAU; NITROBLUE
407-020-2
132885-85-9
Acute Tox. 4; Skin Sens. 1
OXAMITOL
412-510-4
135043-64-0
Acute Tox. 4; Skin Sens. 1
427-680-5
188907-52-0
Eye Dam. 1; Skin Sens. 1
FAP
402-230-0
399-95-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
202-214-1
93-05-0
Acute Tox. 3; Skin Corr. 1B
202-807-5
99-98-9
Acute Tox. 3
200-453-6
60-09-3
Carc. 1B
yes
204-616-2
123-30-8
Muta. 2; Acute Tox. 4
VMZ95005
418-100-1
172964-15-7
Skin Sens. 1
4-BROM-2-CHLORFLUORBENZOL; 4-BROMO-2-CHLOROFLUOROBENZENE
405-580-2
60811-21-4
Acute Tox. 4; Skin Irrit. 2
201-793-8
88-04-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
216-381-3
1570-64-5
Acute Tox. 3; Skin Corr. 1A
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
221-627-8
3165-93-3
Carc. 1B; Muta. 2; Acute Tox. 3
203-401-0
106-47-8
Carc. 1B; Acute Tox. 3; Skin Sens. 1
CHLORO ESTER; CHLOROESTER
410-950-1
69788-75-6
Skin Sens. 1
203-402-6
106-48-9
Acute Tox. 4
ACC ETHER
405-260-2
94050-51-8
Acute Tox. 4; Skin Sens. 1
203-176-9
104-12-1
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
203-397-0
106-43-4
Acute Tox. 4
204-581-3
122-88-3
Acute Tox. 4
CORANOL
420-630-3
83926-73-2
Eye Dam. 1
401-130-4
71526-07-3
Skin Sens. 1
DIAZO-A-SALICYLSULFONATE
404-980-4
124737-31-1
Self-react. C; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
205-855-5
156-43-4
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
ZOLDINE (R) MS-52
410-470-2
137796-06-6
Skin Corr. 1B; Skin Sens. 1
RO 827
412-090-2
2788-74-1
Acute Tox. 4; Skin Sens. 1
432-560-0
61721-07-1
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
438-670-5
87199-17-5
Skin Sens. 1
217-862-0
1987-50-4
yes
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-
yes
430-840-7
202483-63-4
Skin Sens. 1
259-980-5
56073-10-0
Repr. 1A; Acute Tox. 1; STOT RE 1
204-626-7
123-42-2
Eye Irrit. 2
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
2-METHOXY-4-METHYL-6-METHYLAMINO-1,3,5-TRIAZIN; DPX-L5296; L5296
401-360-5
5248-39-5
Acute Tox. 4; STOT RE 2
425-860-8
125971-57-5
Skin Sens. 1
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
209-544-5
584-84-9
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
202-453-1
95-80-7
yes
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4

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