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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021.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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434-480-1
32047-53-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
BLAU MUB 557
419-520-8
172890-93-6
Skin Sens. 1
451-430-4
500717-36-2
Eye Dam. 1; Skin Sens. 1
422-950-9
17193-28-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1
201-162-7
78-96-6
Skin Corr. 1B
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
T-5914 AND 501006025007
421-340-1
6777-05-5
Acute Tox. 4
422-900-6
158894-67-8
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Skin Sens. 1
1-BROM-3,4,5-TRIFLUORBENZOL; 1-BROMO-3,4,5-TRIFLUOROBENZENE
418-480-9
138526-69-9
Flam. Liq. 3; Carc. 2; Skin Irrit. 2; Eye Dam. 1
1-BROM-3,5-DIFLUORBENZOL; 1-BROMO-3,5-DIFLUOROBENZENE; BDFB
416-710-2
461-96-1
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
BROMIDE 182,780
422-850-5
148757-89-5
Skin Sens. 1
203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
ENS 119
402-680-8
26576-84-1
Acute Tox. 4
209-990-0
600-25-9
Acute Tox. 4
203-439-8
106-89-8
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
202-809-6
100-00-5
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 2
GM 102 E
411-370-1
82857-68-9
Acute Tox. 3; Eye Dam. 1
203-696-6
109-69-3
Flam. Liq. 2
414-380-4
140681-55-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
208-846-4
543-59-9
Flam. Liq. 2; Acute Tox. 4
208-749-7
540-54-5
Flam. Liq. 2; Acute Tox. 4
421-080-7
161462-35-7
STOT RE 2
CHINOLONCARBONSÄURE 93-073; CP-70,335
413-760-7
93107-30-3
Repr. 2
O-NITROBENZALDEHYDDIMETHYLACETAL
423-830-9
20627-73-0
Skin Sens. 1
203-556-4
108-16-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
418-440-0
136997-71-2
Skin Sens. 1
211-420-0
644-64-4
Acute Tox. 3; Acute Tox. 4
SURFADONE LP-300 SURFACTANT
403-730-1
2687-96-9
Skin Corr. 1B; Skin Sens. 1
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
216-374-5
1569-02-4
Flam. Liq. 3; STOT SE 3
MEM
418-250-8
65756-41-4
Muta. 2
MEP
418-200-5
69227-51-6
Muta. 2
419-570-0
195006-58-7
Acute Tox. 4
201-091-1
78-18-2
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
418-330-2
162241-33-0
Expl. 1.1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
219-989-7
2592-95-2
Expl. 1.3
602-929-2
123333-53-9
Expl. 1.3
434-120-3
1380001-48-8
Skin Sens. 1
204-318-2
119-38-0
Acute Tox. 1; Acute Tox. 2
203-539-1
107-98-2
Flam. Liq. 3; STOT SE 3
METHOXYISOPROPYLAMINE
422-550-4
37143-54-7
Flam. Liq. 2; Skin Corr. 1B; Acute Tox. 4
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
431-180-2
5271-27-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
424-160-1
139481-22-4
Acute Tox. 4
423-960-6
139756-01-7
Acute Tox. 4; STOT RE 2
210-946-8
626-38-0
Flam. Liq. 3
210-484-7
616-47-7
Acute Tox. 4; Skin Corr. 1B
243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
205-138-7
134-32-7
Acute Tox. 4
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
203-544-9
108-03-2
Flam. Liq. 3; Acute Tox. 4
N-N-OCTYLCAPROLACTAM; N-OCTYLCAPROLACTAME
420-040-6
59227-88-2
Skin Corr. 1B; Skin Sens. 1
200-752-1
71-41-0
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
202-155-1
92-43-3
Acute Tox. 4
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
ARCOSOLV PTB; ARCOSOLV(R) PTB
406-180-0
57018-52-7
Flam. Liq. 3; Eye Dam. 1
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
214-012-0
1072-63-5
Repr. 1B
yes
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 1
432-840-2
220926-97-6
Acute Tox. 4
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
BLEU DISPERSE 370; BLEU DISPERSO 370; BLEU LIP 6994; C.I. DISPERSE BLUE 370; DISPERS BLAU 370; DISPERSE BLUE 370
403-010-7
106359-94-8
Skin Sens. 1
BLEU 1047679; BLUE 1047679
405-200-5
104366-25-8
Skin Sens. 1
BLEU 1044098; BLUE 1044098
405-190-2
122371-93-1
Skin Sens. 1
282-263-3
84145-37-9
Flam. Liq. 3
203-872-2
111-46-6
Acute Tox. 4
225-208-0
4719-04-4
Acute Tox. 4; Skin Sens. 1
EPIKOTE YX4000; EPIKOTE YX4000H; YX-4000
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
216-853-9
1680-21-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-312-7
105-59-9
Eye Irrit. 2
214-237-4
1116-54-7
Carc. 1B
221-070-0
2997-92-4
Acute Tox. 4; Skin Sens. 1
2,2'-AZOBIS(2-METHYL-N-(2-HYDROXYETHYL)PROPIONAMID)
429-090-3
61551-69-7
Skin Sens. 1
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
TG-SA
411-570-9
41481-66-7
Skin Sens. 1
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
203-865-4
111-40-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
200-733-8
70-30-4
Acute Tox. 3
219-799-4
2536-05-2
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
223-791-6
4074-88-8
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-874-3
111-48-8
Eye Irrit. 2
209-855-6
594-82-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
207-346-3
464-06-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-266-4
564-02-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
KHUSINIL
422-580-8
75490-39-0
Acute Tox. 4
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
208-759-1
540-84-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
FR-1034
408-020-5
109678-33-3
Skin Sens. 1
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
Skin Sens. 1
239-701-3
15625-89-5
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
DMBA
424-090-1
10097-02-6
Eye Dam. 1
430-580-4
-
Skin Irrit. 2

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