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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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 28 March 2024. Database contains 4753 unique substances/entries.
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202-273-3
93-76-5
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-467-8
95-95-4
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
-
21436-97-5
Carc. 1B; Acute Tox. 3
203-600-2
108-62-3
Flam. Sol. 2; Repr. 2; Acute Tox. 3
T3P
422-210-5
68957-94-8
Skin Corr. 1B
423-560-1
161717-32-4
Skin Sens. 1
203-614-9
108-77-0
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
204-639-8
123-63-7
Flam. Liq. 3
ESACURE TZT 100
403-150-9
954-16-5
Acute Tox. 4; Eye Irrit. 2
210-027-1
602-99-3
Expl. 1.1; Acute Tox. 4
211-187-5
632-92-8
Expl. 1.1; Acute Tox. 4; STOT RE 2
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
201-865-9
88-89-1
Expl. 1.1; Acute Tox. 3
201-436-6
82-71-3
Expl. 1.1; Acute Tox. 4
204-289-6
118-96-7
Expl. 1.1; Acute Tox. 3; STOT RE 2
202-013-9
90-72-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
429-610-9
1030366-98-3
Acute Tox. 4; Eye Dam. 1
429-600-4
1026988-42-0
Acute Tox. 4; Eye Dam. 1
BASISCH GELB 8511
407-010-8
118208-02-9
Acute Tox. 4; Eye Dam. 1
202-361-1
94-75-7
Acute Tox. 4; STOT SE 3; Eye Dam. 1; Skin Sens. 1
202-366-9
94-82-6
Acute Tox. 4
223-383-8
3864-99-1
yes
CYCLOWOOD
405-340-7
13019-04-0
Skin Irrit. 2
218-256-9
2095-02-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
424-870-1
27624-67-5
Expl. 1.1; Eye Dam. 1
DAMP
410-330-0
54236-98-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
254-323-9
39156-41-7
Carc. 1B; Muta. 2; Acute Tox. 4
210-406-1
615-05-4
Carc. 1B; Muta. 2; Acute Tox. 4
2,4-DICHLORO-3-ETHYL-6-NITROPHENOL
420-740-1
99817-36-4
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
PM 9879
401-060-4
121518-45-4
Skin Corr. 1B
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
204-429-6
120-83-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
429-310-8
57987-55-0
Eye Dam. 1
UK-51,060-01
412-390-3
86386-75-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
434-820-9
106461-41-0
STOT RE 2
ADK ARKLS SV-3
419-090-1
129205-19-2
Skin Sens. 1
CG 27-145
411-220-5
134701-20-5
Skin Irrit. 2; Skin Sens. 1
209-649-6
589-43-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-294-7
565-80-0
Flam. Liq. 2; Acute Tox. 4
203-548-0
108-08-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
202-553-5
97-02-9
Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-087-7
51-28-5
Acute Tox. 3; Acute Tox. 2; STOT RE 1
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
203-321-6
105-67-9
Acute Tox. 3; Skin Corr. 1B
LYRISAL
405-690-0
114119-97-0
Skin Irrit. 2; Skin Sens. 1
MR-8A; MR-N2; NBDI
411-280-2
161973-12-2
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
DIAZO W 6623-TS
413-290-2
93672-52-7
Self-react. C; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
430-170-5
114625-74-0
Acute Tox. 4

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