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 24 svibnja 2024. Database contains 4917 unique substances/entries.
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UK-103,449-BV
427-100-0
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
OA 8523
402-460-1
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Skin Irrit. 2; Skin Sens. 1
Details
TFA-4713
418-960-8
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Skin Corr. 1B; Skin Sens. 1
Details
444-320-2
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Acute Tox. 4
Details
430-790-6
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Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
430-730-9
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Eye Dam. 1
Details
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VPVB very Persistent and very Bioaccumulative (article 57e)
Details
430-580-4
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Skin Irrit. 2
Details
424-660-8
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STOT RE 2; Eye Dam. 1; Skin Sens. 1
Details
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2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 | CAS no: 80-54-6
(2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-30-2
(2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - | CAS no: 75166-31-3
799-970-2
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R Toxic for reproduction (article 57c)
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ATRAC 869
417-960-5
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
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2-ethylhexanoic acid EC / List no: 205-743-6 | CAS no: 149-57-5
Metal salts of 2-ethylhexanoic acid EC / List no: - | CAS no: -
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Repr. 1B
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4,4'-oxydianiline EC / List no: 202-977-0 | CAS no: 101-80-4
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Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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VPVB very Persistent and very Bioaccumulative (article 57e)
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VPVB very Persistent and very Bioaccumulative (article 57e)
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VPVB very Persistent and very Bioaccumulative (article 57e)
Details
441-550-5
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Self-react. C; Carc. 2
Details
701-162-1
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Repr. 1B
Details
701-271-4
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Repr. 1B; Eye Irrit. 2
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
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Eye Dam. 1
Details
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
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