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 21 lipnja 2024. Database contains 4917 unique substances/entries.
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BROWN JR 543
414-150-3
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Skin Sens. 1
Details
BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763
404-540-1
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Skin Sens. 1
Details
MS6119
415-190-4
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Skin Sens. 1
Details
HOSTACOR 4205 CONC.; HOSTACOR V 4205
413-500-2
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Skin Irrit. 2; Eye Dam. 1
Details
BLENDUR I VP KU 3-4519
421-550-1
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Carc. 1B; Repr. 1B; Skin Sens. 1
Details
HFR-990
423-180-6
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STOT RE 2
Details
PIGMENTADDITIV P
411-310-4
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Eye Dam. 1
Details
ACRYLSKUM; T-2816 FOAMER
407-810-7
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STOT RE 2
Details
DISPERSIONSROT 2754
411-880-4
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Skin Sens. 1
Details
34 DIAZO
417-080-1
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Self-react. D; Skin Sens. 1
Details
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
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Muta. 2; Skin Sens. 1
Details
SP 7077
430-180-1
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Skin Irrit. 2
Details
OLOA 224 (OIL FREE)
420-470-4
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Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
REACTIVE YELLOW FC 75560
419-450-8
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Skin Sens. 1
Details
VERNETZER TMAG
412-790-8
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Carc. 1B; Muta. 2; STOT RE 2
Details
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
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Skin Sens. 1
Details
RED MDO 358
414-620-8
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Eye Dam. 1; Skin Sens. 1
Details
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
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Skin Sens. 1
Details
P2-800; P2-935LV
415-870-0
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Skin Sens. 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.
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P Parasites
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
Details

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