EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. 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).

Last updated 28 March 2024. Database contains 4876 unique substances/entries.
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419-270-1
123599-82-6
Eye Irrit. 2
Details
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
Details
-
-
Repr. 1B
Details
425-520-9
197179-61-6
Eye Dam. 1
Details
273-688-5
69011-06-9
R Toxic for reproduction (article 57c)
Details
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
Details
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
C.I. DIRECT BLACK 184; C.I. DIRECT NOIR 184
406-000-0
173939-66-7
Eye Dam. 1
Details
NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
402-850-1
-
Eye Dam. 1
Details
BROWN JR 543
414-150-3
-
Skin Sens. 1
Details
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
-
Skin Sens. 1
Details
MS6119
415-190-4
-
Skin Sens. 1
Details
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
-
Skin Irrit. 2; Eye Dam. 1
Details
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
Details
HFR-990
423-180-6
-
STOT RE 2
Details
PIGMENTADDITIV P
411-310-4
-
Eye Dam. 1
Details
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
Details
DISPERSIONSROT 2754
411-880-4
-
Skin Sens. 1
Details
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
Details
CASSIFFIX
422-040-1
426218-78-2
Eye Irrit. 2; Skin Irrit. 2
Details
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
Details
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
Details
SP 7077
430-180-1
-
Skin Irrit. 2
Details
OLOA 224 (OIL FREE)
420-470-4
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
AZUL MARINHO 018112; BLEU MARINE 018112; NAVY 018112; NAVY BLUE 018112
405-665-4
118685-33-9
Skin Sens. 1
Details
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
Details
PACIFIED REACTIVE BLACK 31
423-940-7
85585-91-7
Eye Dam. 1
Details
REACTIVE YELLOW FC 75560
419-450-8
-
Skin Sens. 1
Details
VERNETZER TMAG
412-790-8
-
Carc. 1B; Muta. 2; STOT RE 2
Details
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
Details
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
-
Skin Sens. 1
Details
DUASYN DIREKTSCHWARZ HEF-SF VP 332
411-890-9
108936-08-9
Acute Tox. 4; Eye Dam. 1
Details
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
Details
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1
Details
RED MDO 358
414-620-8
-
Eye Dam. 1; Skin Sens. 1
Details
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
-
Skin Sens. 1
Details
P2-800; P2-935LV
415-870-0
-
Skin Sens. 1
Details
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
Details
615-339-5
71751-41-2
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
Details
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-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
Details
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-
P Parasites
Details
250-241-2
30560-19-1
Acute Tox. 4
Details
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
Details
200-836-8
75-07-0
Flam. Liq. 1; Carc. 1B; Muta. 2; Eye Irrit. 2; STOT SE 3
Details
200-473-5
60-35-5
Carc. 2
Details
603-921-1
135410-20-7
Repr. 2; Acute Tox. 3
Details
682-791-8
160430-64-8
Repr. 2; Acute Tox. 3
Details
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
Details

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