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 18 travnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predominantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.
292-660-3
90669-78-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
295-523-6
92062-09-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of low-melting slack wax with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-155-9
97863-04-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with bentonite for removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-156-4
97863-05-3
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-525-7
92062-11-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the treatment of low-melting petroleum slack wax with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
308-158-5
97863-06-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-524-1
92062-10-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
265-165-5
64742-61-6
Carc. 1B
Details
Substance obtained as a powdery cathodic precipitate during the electrolytic decoppering stage of copper refining electrolysis. Consists primarily of copper with antimony, arsenic, lead and nickel in metallic form as well as oxides and sulfates.
305-433-1
94551-87-8
Carc. 1A; Muta. 2; Repr. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
Product obtained from recycling of the end electrolyte of copper refining electrolysis followed by evaporation to separate the residual sulfuric acid. Consists primarily of nickel and iron sulfates with small amounts of the sulfates of zinc, alkali earths and alkali metals.
295-859-3
92129-57-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
231-132-9
7440-23-5
Water-react. 1; Skin Corr. 1B
Details
C.I. BASIC BLUE 163
407-340-2
124719-24-0
Eye Dam. 1
Details
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
Skin Sens. 1
Details
SÄUREBRAUN 6230
401-220-3
-
Acute Tox. 4
Details
426-520-1
71420-85-4
Skin Sens. 1
Details
EURESYNTH(R) 5010
418-720-2
-
Flam. Sol. 1; Water-react. 1; Pyr. Sol. 1; Acute Tox. 4; Skin Corr. 1A
Details
DUPLOSAN-DP-NATRIUM; DUPOLSON-DP-NATRIUM
413-340-3
119299-10-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
420-800-7
1379804-37-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
422-100-7
102061-82-5
Eye Dam. 1; Skin Sens. 1
Details
REACTIVE ORANGE TZ 3931
413-990-8
149850-31-7
Skin Sens. 1
Details
224-580-1
4418-26-2
Acute Tox. 4
Details
FAT 40'436; FAT 40'436/A; REACTIVE ORANGE TZ 3538
410-770-3
146177-84-6
Skin Sens. 1
Details
434-360-9
91125-43-8
Eye Dam. 1; Skin Sens. 1
Details
430-890-1
81992-66-7
Skin Sens. 1
Details
NSGBB; YELLOW BROWN E-GLN
412-320-1
31361-99-6
Eye Dam. 1
Details
BENZOYL BISULFITE
410-680-4
1379676-76-2
Skin Sens. 1
Details
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
NA-2-ETHYLHEXANOLAT
406-150-7
38411-13-1
Flam. Sol. 1; Skin Corr. 1B
Details
AF-365
405-510-0
121216-78-2
Skin Irrit. 2; Skin Sens. 1
Details
AF-390
407-720-8
155160-86-4
Skin Sens. 1
Details
H: SÄUREGELB 2829
401-870-8
115035-41-1
Eye Dam. 1
Details
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
Details
BENZTRIAZOL UV ABSORBER BUK 4499; BUK 4499; UV ABSORBER BUK 4499
403-080-9
92484-48-5
Eye Dam. 1
Details
418-410-7
139122-78-4
Eye Irrit. 2
Details
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
Details
-
4312-97-4
Acute Tox. 4
Details
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
Details
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1
Details
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
Details
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
Details
BISULPHITE ADDUCT; GR59658A
406-190-5
54322-20-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
425-460-3
1379676-84-2
Skin Sens. 1
Details
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
Details
263-560-7
62476-59-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
Details
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
Details
247-852-1
26628-22-8
Acute Tox. 2
Details
LU20
405-450-5
66531-87-1
Skin Sens. 1
Details
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
Details

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