| Question | Answer | Material Number |
| 1. Phthalate-free products | ||
| Medical equipment and associated consumables must not contain the phthalates (esters of 1,2-benzenedicarboxylic acid) listed below. The total content of phthalates must not exceed 0.1% by weight in each individual part of the product. | --> Phthalates are covered via our certificates for REACH (Some Phthalates are SVHCs on the candidate list), RoHS for electrical parts of the System, and the declaration to MDR Annex II article 10.4. | |
| Documentation proving that the requirement is met must be available from the supplier and sent to the Region. Such documentation can be analysis reports, full content declarations, or certificates from manufacturers. | Besides this, we do not expect to have phthalates used in our products but have no further information from suppliers. | |
| Substance: | ||
| Di(2-ethylhexyl) phthalate (DHEP), CAS number 117-81-7 | ||
| Bis(2-metoxietyl) phthalate; Di(2-metoxietyl) phthalate (BMEP; DMEP), CAS number 117-82-8 | ||
| Di-N-Pentylphthalate (DPP), CAS number 131-18-0 | ||
| Diisopentyl ftalat (DIPP), CAS number 605-50-5 | ||
| 1,2-Benzenedicarboxylic acid, di-C7-11 – branched and linear alkyl esters (DHNUP), CAS number 68515-42-4 | ||
| di-C6-8-branched alkyl esters (DIHP), CAS number 71888-89-6 | ||
| n-pentyl-isopentylphthalate, CAS number 776297-69-9 | ||
| Diisobutyl phthalate (DIBP), CAS number 71888-89-6 84-69-5 | ||
| Dibutyl phthalate (DBP), CAS number 84-74-2 | ||
| Dihexyl phthalate (DnHP), CAS number 84-75-3 | ||
| 1,2-benzene dicarboxylic acid dipentylester, branched and linear, CAS number 84777-06-0 | ||
| Benzyl butyl phthalate (BBP), CAS number 85-68-7 | ||
| 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear, CAS number 68515-50-4 | ||
| 1,2-Benzenedicarboxylic acid, di-C6-10 alkyl ester, CAS number 68515-51-5 | ||
| 1,2-Benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters, CAS number 68648-93-1 | ||
| Diisononyl phthalate (DINP), CAS number 28553-12-0 and 68515-48-0 | ||
| Diisodecyl phthalate (DIDP), CAS number 26761-40-0 and 68515-49-1 | ||
| di-n-octyl phthalate (DNOP), CAS number 117-84-0 | ||
| 2. Hormone-disrupting substances | ||
| The supplier must indicate whether there are any known hormone-disrupting substances in the offered products | Hormone-disrupting substances are covered via our certificates for REACH (as SVHCs on the candidate list) and the declaration to MDR Annex II article 10.4. Besides this, no further information from suppliers that we have Hormone-disrupting substances used in our product. | |
| 3. Do the consumables contain any phthalates? If yes, specify which ones. | No indication the use of Phthalates in our product via REACH & RoHS certificates or from additional documentation (e.g. Datasheets) | |
| 4. Do the consumables contain any plasticizers? If yes, specify which ones. | No indication for the use of plasticizer in our product via REACH & RoHS certificates or from additional documentation (e.g. Datasheets) | |
| 5. Do the consumables contain substances on the candidate list (Article 59 of Regulation (EC) No 1907/2006 REACH)? If yes, enter the CAS number and content. | No, according to the supplier REACH certificates | |
| 6.Do the consumables contain the cyclic silicones D4 (CAS 556-67-2), D5 (CAS 541-02-6) or D6 (CAS 540-97-6)? If yes, enter the percentage. | Covered via REACH as D4, D5, and D6 are on the candidate list: The product does not contain cyclic silicones D4, D5 & D6 above a concentration of 0,1 wt% per used article/component according to the certificates we received | |
| 7. Do the consumables contain CMR substances? | Covered via Statement to MDR Annex II article 10.4.: No, the consumables do not contain CMR substances in a concentration above 0,1 wt% according to the certificates we receive. | |
| 8. Do the consumables contain any antimicrobial substances? If yes, specify which ones. | No | |
| 9. For consumables that stick to the skin, do they contain any known allergens or irritants? If yes, state what. | No, to the best of our knowledge (depends on the "List of allergens or irritants as this might change frequently) | |
| 10. The packaging of the products offered in this section is made of at least 50% recycled material. YES/NO | ||
| ACCU-CHEK INSTANT MMOL/L SC SET | Yes - 95% | 09221808054 |
| ACCU-CHEK INSTANT 50CT STRIP EURO4 | No | 07819382133 |
| Accu-Chek Instant controls intl 2 | No | 07869525020 |
| Accu-Chek Guide Kit mmol/L FC (FI. SE) | Yes - 95% | 07400918057 |
| Accu-Chek Guide Test Strip 50CT EU 3 | No | 07453736057 |
| Accu-Chek guide 2-level controls intl 1 | No | 07748906171 |
| AC Fastclix Kit | No - fresh fiber | 07522851170 |
| AC FastClix-lancet (sis.204) | No - fresh fiber | 05208491001 |
| AC Mobile LCM meter | Yes - 95% | 06383602057 |
| AC Mobile Test Cassette (sis.50) | No - fresh fiber | 07141254370 |
| AC Mobile -controls (si.4) | No - fresh fiber | 05191165190 |
| AC Aviva Test Strip | No | 06453970170 |
| AC Aviva controls (sis.2) | No | 04455215001 |
| AC Softclix | No - fresh fiber | 03307450001 |
| AC Softclix -lancet (sis.200) | No - fresh fiber | 03307484001 |
| 11. the production site of the product offered has a certified ISO 13485 quality management system or an equivalent quality management system certificate, such as the production site’s own, which closely follows the ISO 13485 standard. YES/NO, if YES insert certificates/production site. | ||
| Accu-Chek Instant MMOL/L SC Set | Altek | 09221808054 |
| Accu-Chek Instant 50CT Strip EURO4 | RDCI | 07819382133 |
| Accu-Chek Instant controls intl 2 | Bionostics | 07869525020 |
| Accu-Chek Guide Kit mmol/L FC (FI. SE) | Sanmina India | 07400918057 |
| Accu-Chek Guide Test Strip 50CT EU 3 | RDCI | 07453736057 |
| Accu-Chek guide 2-level controls intl 1 | Bionostics | 07748906171 |
| AC Fastclix Kit | Weidmann + Gerresheimer | 07522851170 |
| AC FastClix-lancet (sis.204) | Weidmann + Gerresheimer | 05208491001 |
| AC Mobile LCM meter | Altek | 06383602057 |
| AC Mobile Test Cassette (sis.50) | RDCG | 07141254370 |
| AC Mobile -controls (si.4) | bionostics | 05191165190 |
| AC Aviva Test Strip | RDCI | 06453970170 |
| AC Aviva controls (sis.2) | Bionostics | 04455215001 |
| AC Softclix | HTL + Asahi | 03307450001 |
| AC Softclix -lancet (sis.200) | HTL + Asahi | 03307484001 |
| 12. Whether PVC or other halogenated plastics or plasticizers (phthalates) of PVC is used in the PRODUCT offered. YES/NO If YES, in which part of the product and what measures the bidder has planned to conclude during the contract period to replace such materials in products? |
||
| AC Instant MMOL/L SC Set |
No use of PVC or other halogenated plastics or plasticicers of PVC. In addition, the use of hazardous plasticizers is addressed within RoHS-Directive REACH, MDand IVD Regulations. REC products have to be compliant with the REACH, RoHS, MDR, and IVDR Requirements.
|
09221808054 |
| AC Instant 50CT STRIP EURO4 | 07819382133 | |
| AC Instant controls intl 2 | 07869525020 | |
| 13. PVC is in general not classified as a toxic or hazardous substance. Only plasticizers that might be used during PVC production/synthesis can be classified as hazardous substances. The Use of hazardous plasticizers is addressed within RoHs-Directive and REACH-, MD- and IVD Regulations. RDC products have to be compliant with tothe REACH-, RoHS-, MDR-, and IVDR-Requirements. |
||
| Accu-Chek Guide Kit mmol/L FC (FI. SE) |
No use of PVC or other halogenated plastics or plasticizers of PVC. In addition, the use of hazardous plasticizers is addressed within RoHS-Directive REACH, MDand IVD Regulations. REC products have to be compliant to the REACH, RoHS, MDR and IVDR Requirements.
|
07400918057 |
| Accu-Chek Guide Test Strip 50CT EU 3 | 07453736057 | |
| Accu-Chek guide 2-level controls intl 1 | 07748906171 | |
| AC Fastclix Kit | 07522851170 | |
| AC FastClix-lancet (sis.204) | 05208491001 | |
| AC Mobile LCM meter | 06383602057 | |
| AC Mobile Test Cassette (sis.50) | 07141254370 | |
| AC Mobile -controls (si.4) | 05191165190 | |
| AC Aviva Test Strip | 06453970170 | |
| AC Aviva controls (sis.2) | 04455215001 | |
| AC Softclix | 03307450001 | |
| AC Softclix -lancet (sis.200) | 03307484001 |