w CORMAY EC DECLARATION OF CONFORMITY In accordance with Directive 98/79/EC We, PZ CORMAY S.A., 22 Wiosenna Str., 05-092 Lomianki, Poland, declare that the following devices Devices name: See ATTACHMENT 1 Catalogue number: See ATTACHMENT 1 (classified as other IVDD ~ all devices with exception of devices listed in List A and List B and self-testing devices) comply with essential requirements of the ANNEX | ~ Directive 98/79/EC and their conformity assessment has been made accuruirigly tu Ue ANNEX Il ~ Directive Y8//9/EC. The devices named above have been designed and manufactured according to the specifications: EN 13619-2006 Performance evaluation of in vitro diagnostic medical devives. EN ISO 14971:2012 Medical Devices - Application of risk management to medical devices. CN 150 15223-1.2021, symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements. EN ISO 18113-1:2011 Invitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements, EN ISO 18113-2:2011 Invitro. diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 2: n vitro diagnostic reagents tor professional use. FN ISO 236402015 Invitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents. PZ CORMAY S.A Quality Management System complies with requirements of ISO 9001:2015 and EN ISO 12426-2916 standards and has been approved by Lloyd's Register Quality Assurance Limited in the range concerning design, production and distribution of reagents of in vitro diagnostics for medical, industrial and scientific laboratories and design, production, sales and maintenance ami | YL... ‘Wojclech suchoWsk' C Signature’ Flovio Finotello Vice President of Management Board of Vice President of Management Board of PLCORMAY S.A, PZ CORMAY S.A. Place: Lomianki Date: 25 May 2022 th ob Dk Sse Page 1/5 P2Cormay S.A | Wiosenna 22 Stes, 05082 tomiank| MIP: 1161872269 REGON: 140777556 J +48 (22) 7517910] m affice@coxmayol wun cormayatww CORMAY aise aS Te 1 4-216 PRESTIGE 24i LQ ALAT 2 [ aie | peice 2a AAT 2 4-238 PRESTIGE 241 LQ ALBUMIN i} 4 4-438 PRESTIGE 24i LQ ALBUMIN s 4-212 PRESTIGE 24i LQ ALP 6 4-412 PRESTIGE 24i LO. ALP 7 carsis | esti 24 alpha TANTS aa paeence TALIA TART 9 4-314 PRESTIGE 24i ALPHA 1-GLYCOPROTEIN ACID 10 4-340 PRESTIGE 24i ALPHA 1-GLYCOPROTEIN ACID i 4-255 PRESTIGE 24i LQ. AMYLASE [ass Pes 2. AMMLASE [ae pesmi ata. AMMLASe EPS 14 4-476 PRESTIGE 24i LQ AMYLASE EPS. 1s, 4-275 PRESTIGE 24i APOLIPOPROTEIN B 16 4-334 PRESTIGE 24i APOLIPOPROTEIN B 37 [ai | esis 2a AS : 1 4-414 PRESTIGE 24] LQ ASAT 7 19 4-270 PRESTIGE 241 ASO 20 4-489 PRESTIGE 241 ASO 21 4-248 PRESTIGE 24i LO. BIL DIRECT 22 ass | nese 2 ORECT 23 4-245 PRESTIGE 24i LQ BIL TOTAL 24 4-445 PRESTIGE 24i LQ BIL TOTAL 254345 pesmi ae actos 26 4-495 PRESTIGE 24i BILE ACIDS 27 4-251 PRESTIGE 24i LQ CALCIUM 2a | isi peice ante eaLeTUM 29 4-247 PRESTIGE 24i CALCIUM ARSENAZO. 30 4-447 PRESTIGE 24i CALCIUM ARSENAZO- 31 4-312 PRESTIGE 24i CERULOPLASMIN 227] 438 nESTIGE 2 CERULOPLASMIN =a] 204 | peer ate ovo signature; << signature ( i Flavio Finotello Wojciech Suchowski Vice President of Management Board of Vice President of Management Board of PZCORMAY S.A. PZ CORMAY S.A. Place: Lomianki Date: 25 May 2022 PZCormay S.A. | Wiosenna 22 Steet, 05-082 omianki| IP: 1181872269 REGON: 140777556] .J 148 22) 15119 10|moffice@eormay pl wen.cormay ahww CORMAY No | CatNo Nome 34 | 4-404 | PRESTIGE 24110 CHO 35 | 4-256 | PRESTIGE 241 CHOLINESTERASE 36_[ 4-456 | PRESTIGE 241 CHOLINESTERASE 37 | 4-220 | PRESTIGE 241 LQ CK 3e_| 4420 | pnestict 24ita ck 39 | 4-227 | PRESTIGE 241 10 CK-MB iil 40 | 4-427 | PRESTIGE 241 LQ CK-MB a 4-309 __| PRESTIGE 241 COMPLEMENT C3. 42 [4-335 | PRESTIGE 241 COMPLEMENT C3 a3 [4310 _| prestiGt 241 COMPLEMENT Ca, 44 | 4-336 | PRESTIGE 241 COMPLEMENT Ca 45_| 4-237 | PRESTIGE 241 CREA ENZYMATIC 46_| 4-437 _| PRESTIGE 24i CREA ENZYMATIC. [a7 [4-233 | PRESTIGE 241Q CREATININE 48 [4433 | PRESTIGE 24 LQ CREATININE 49 [4-261 | PRESTIGE 2aicRP LUTRA so | 4-480 | PRESTIGE 24i CRP ULTRA Si_|" 4200 __| PRESTIGE 241 CYSTATINC 3z_| 4-400 | PRESTIGE 241 CYSTATINC 53 | 4246 | PRESTIGE 241 D-DIMER Sa | a-aas | PRESTIGE 7ai n-niMeR 55 | 4223 | PRESTIGE 241 dTIBC 56_[ 4-440 | PRESTIGE 241 dTIBC 37 | 4378 | PRESTIGE 247 ETHANOL 58_| 4-478 | PRESTIGE 241 ETHANOL 59 | 4-264 | PRESTIGE 241 FFRRITIN 4-483 | PRESTIGE 241 FERRITIN 4-258 _| PRESTIGE 241 LQ FERRUM o2_| "4-458 | PRESTIGE 241 LQ FERRUM [e2 | 4313 | prestiGe 241 FipRINoGEN 64_| 4-339 | PRESTIGE 241 FIBRINOGEN. 65 | 4-224 | PRESTIGE 241LQ GGT [66 4-424 _ | PRESTIGE 241 LQ GGT o7_| 4-201 | PRESTIGE 241 10. GLUCOSE ce | 4401 | PResTIGe 24i La GLUCOSE Flovio Finotello Sera “i i WoJclech suchow: Vice President of Management Board of Vice President of Management Board of PZCORMAY S.A, Place: Lomianki PZ. CORMAY S.A. Date: 25 May 2022 Page 3/5 PL Cormay S.A. | Wiosenna 22 Street, 05-082 Lomianki| NIP: 1181872268 | REGON: 140777556]. +48 (22) 751 7910] m office@eormay.pl wecormay plWw CORMAY No [Gat no Name so _| 4231 _ | PRESTIGE 241 GLUCOSE HEX 70 4-423 _ | PRESTIGE 241 GLUCOSE HEX 71_[ 4-311 __| PRESTIGE 24i HAPTOGLOBIN 72_[ 4-337 _| PRESTIGE 241 HAPTOGLOBIN 73_[ #300 | PRESIIGE 24rHDAic DIRECT 74_| 4-201 _| PRESTIGE 247 HbA DIRECT 754-179 | PRESTIGE 241 HDL DIRECT 75 [4-479 _| PRESTIGE 241 HDL DIRECT 7_[ 4-271 | PRESTIGE 241 IgA 75 [#330 | PRESTIGE 2arigA\ 79_| 4.272 _| PRESTIGE 241 IgG 30 | 4-331 _ | PRESTIGE 241 eG st_| 4-273 __| PRESTIGE 24iigM &_[ 4-332 | PRESTIGE 24i ie & | 4-386 | PRESTIGE 24i LACTATE e1_[ 4.466 _| PRESTIGE 241 LACTATE & | 4-239 | PRESTIGE 24iLQ.LDH 86 | 4-439 | PRESTIGE 24iLQLDH 87_[ 4-180 | PRESTIGE 241 LDL DIRECT 36 | 4-490 | PRESTIGE 241 LDL DIRECT s [4495 | paEsTice 24iLQUiPAse 30_| 4-329 __| PRESTIGE 241 LQLIPASE st_| 4-222 | PRESTIGE 241 LO LIPASE S2_| 4-422 | PRESTIGE 241 LA LIPASE s3_| 4-263 | PRESTIGE 24/ LIPOPROTEIN (@) 32_| 4-482 | PRESTIGE 241 LIPOPROTEIN (a) 35_| 4-229 | PRESTIGE 2410 MG 36_| 4-829 | PRESTIGE 24/ LMG 57_| 0-462 | PRESTIGE 241 LMG 35_ | @-24q | PRESTIGE 24rMICKUALBUMIT o_| 4.444 | PRESTIGE 241 MICROALAUMIN 700_| 4-262 | PRESTIGE 24i MYOGLOBIN 201 | 4-481 | PRESTIGE 24i MYOGLOBIN 302 | 4-243 | PRESTIGE 24i LQ PHOSPHORUS 103 | _a-aa3 | PRESTIGE 26rLQ PHOSPHORUS Signature: wai (l, Signature: @ Flavio Fnotello Wojciech Suenowsk Vice President of Management Board of Vice President of Management Board of PZ CORMAY S.A PZ CORMAYS.A, Place: lmianki hate: 26 May 2972 gia Wasa ETS Page as PL Cormay S.A.| Wlosenna 22 Steet, 05.092 tomlank! | NP: 1181872269 | REGON: 140777556] .9 +48 (22) 75179 10| me ofce@cormay pl wvmw.cormayhw CORMAY No [Cat No Name 304 | 4-269 | PRESTIGE 241 RF 305 | 4-488 | PRESTIGE 241 RF 106 [4-253 __ | PRESTIGE 241LA TG 307 | 4-453 PRESTIGE 241 LQ 16 ana [7-226 _| PRESTIGE 241LQTG mono 109 | 4-426 | PRESTIGE 241 LO TG mono u10 [4-265 | PRESTIGE 241 TOTAL IgE iit | 4-484] PRESTIGE 24i TOTAL IgE 112 [4-236 | PRESTIGE 241LQ TOTAL PROTEIN 113 [4-436 | PRESTIGE 241 LQ TOTAL PROTEIN aia | 4-274 | PRESTIGE 241 TRANSFERRIN ui | 4-333 __| PRESTIGE 24i TRANSFERRIN 116 [4-208 [PRESTIGE 2411Q UA 117 [4-408 | PRESTIGE 241 LQ UA 11 [4-186 _ | PRESTIGE 241 UIBC ui9 | 4-494 | PRESTIGE 24i UiBC 320 | 4-206 | PRESTIGE 2411Q UREA i2i | 4-406 | PRESTIGE 24LQ UREA 322 [4-242 | PRESTIGE 241 URINE PROTEINS 303 [4-442 | PRESTIGE 241 URINE PROTEINS Signature: Signature: f Flavio Finetello Wojciech Suchuwskr Vice President of Management Board of Vice President of Management Board of PZCORMAY S.A, PZCORMAY S.A. Place: Lomianki Date: 25 May 2022 Page 5/5 # MOTTTSSG| +48 22} 7517910 w offieescormay.p| wnw.cormay.pl