—— ____21024315-12 ° ; i United States of America DEPARTMENT OF STATE To all to whom these presents shall come, Greeting: 1 Certify That the document hereunto annexed is under the Seal of the Department of Health and Human Services, United States of America, and that such Seal is entitled to full faith and credit.* “For the contents of the annexed document, the Department assumes no responsibility This certificate is not valid if itis removed or altered in any way whatsoever In testimony whereof, I, Antony J. Blinken, Secretary of State , have hereunto caused the seal of the Department of State to be affixed and my name subscribed by the Assistant Authentication Officer, of the said Department, at the city of Washington, in the District of Columbia, this tenth day of April, 2021. Issued pursuant to CHXIV, State of Sept. 15, 1789, I Stat, 68-69; 22 USC 2657; 22USC 26514; § USC 301; 28 USC 1733 et. oq.: 8 USC 1443); RULE 44 Federal Rules of Civil ProcedureBAN DICH Hop ching quéc Hoa Ky BO NGOAI GIAO Han hanh kinh giri nhimng ngwoi c6 lién quan: ‘Toi xin ching nhan ring van ban dinh kém theo day duge ky va déng con dau cia B6 truéng BY té va Dich vu Nhan sinh, va ring con Dau nay dugc tin tong hoan toan.* *86 Ngogi giao khing chu trdch nhigm vé cic not dung trong vin bin dinh kom. Gildy ching nhén nay khéng c6 gid tr] néu bj théo ri hay stia d6i theo bat ky each nao, Dé ching thyc, tdi, Antony J. Blinken,BO truéng Ngoai giao, d& cho phép déng dau cia Bé Ngoai giao va tén cia minh duge ky béi Quan chitc Hop phdp ho cia B6 trén, tai Thanh phé Washington, District of Columbia ngay 10/04/2021. (da ky va dong déu) Antony J. Blinken B6 trang BO Ngoai giao Can b6 Lanh su, B@ Ngoai giao Ching the 6ng Nguyen Duy Khiém, BE Toi, Nguyén Duy Khiém, Bi the thir Nhat, thie thit Nhat, Dai sie quan CHXHCN Viet Dai ste quin CHXHCN Viét Nam iai Hop Nam tai Hop ching quéc Hoa Kj, da ky ching quéc Hoa Kj, cam doan da dich truoe mat 161. chinh xée van ban nay tit tiéng Anh sang tiéng Viét ae Ngay 14 thang 04 néim 2021 Ng Nguyén Duy Khiémal siz quén music CHXHCN Viet Nam tai Hoa KY Embassy ofthe S.Rof Vietnam inte Unt State of ren ‘CHUNG NHAN / HOP PHAP HOA LANH Sy conser uraccrin ‘oes et Nam Tease dea Antony I BICKER. Se , : eke”. 80 ving ngoai 920 EEE sonomicien foe “ane! Hop chiing quéc Hoa Kiz hg ching i ny pp a inh a ‘arted Sig. Washington D.C gag. 14. 4,-2021 * ihe 1.coqun ci. Dai st quén Vigt Nam tai Hoa KS. 755, HPHI2021 ” asiN U.S. FOOD & DRUG hea esieastiehens ADMINISTRATION Sivr Speng, MD 2056) Certificate No. 3838- CERTIFICATE TO FOREIGN GOVERNMENT In order to allow the importation of United States products into foreign countries , the U.S. Food and Drug ‘Administration (FDA) certifies the following information concerning the product(s) to be exported listed below: Name of Product(s! Name of Manufacturer/Distributor, Address See Attached List See Attached List (Six Pages) (One Page) ‘The product(s) described above (and the manufacturing/distribution site(s) which produces/distributes it) is subject to the jurisdiction of the FDA under the Federal Food, Drug, and Cosmetic Act. {tis certified that the above product(s) may be marketed in, and legally exported from, the United States of America at this time, The manufacturing plant(s) in which the product(s) is produced is subject to periodic inspections. Sincerely, Caz ines CDR Cesar A. Perez, PhD, Director DRP2: Division of Establishment Support Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health ULS. Food and Drug Administration, DHHS This certificate Is valid from January 06, 2021 to January 05, 2023.US. Food & Org Adminiraton imi U.S. FOOD & DRU {0903 New Hampshire ene g ADMINISTRATION She Seng Mb 220 Certificate No. 3838-1-2021 Certificate to Foreign Government - Name of Manufacturer/Distributor Attachment Page 1 of 1 Name of Owner Operator Carestream Health, Inc CCaresiream Health In. 1049 West Ridge Road 180 Verona Street Rochestor, NY USA 14515 Rocheetor, NY USA 14608 [END OF MANUFACTURER/DISTRIBUTOR LIST=: Name of Manufacturer Caresiream Health Inc. 8124 Pacific Ave WHITE CITY, OR USA 97503 CARESTREAM HEALTH, INC. {IMATION WAY OAKDALE, MN USA 55128 ‘Soluciones Medicas Exportacion 8. De RL. De CV. CALLE ANILLO PERIFERICO PONIENTE NO. 3100 ‘COLONIA PARAISOS DEL COLL! ZAPOPAN, Jalisco MEXICO 45069 Rayco (Xiamen) Medical Products Company Limited 308 Wengiiao Road Haicang District XIAMEN, Fujan CHINA 361022 Carestream Health, Inc. £2000 Howard Smith Avenue West Windsor, CO USA 80550 Carestream Health, Inc. 1669 Lake Avenue Rochester, NY USA 14652i) U.S. FOOD & DRUG US. Food & Brug Administ ADMINISTRATION ver ping 288 Poa Tears pore rtficate No. 3838-1-2021 Certificate to Foreign Government - Name of Product(s) Attachment Page 1 of 6 Name of Owner Operator ‘Carestream Heath ne 150 Verona Steet Rochester, NY USA 14608 Name of Manufacturer (Carestream Heat, Ine 8124 Pate Ave WHITE CITY, OR USA 97503 Sclucionas Medicas Experacion S. Ds RL, Do Cv. (CALLE ANILLO PERIFERICO PONIENTE NO. 3100, COLONIA PARAISOS DEL COLL ZAPOPAN, Jalico MEXICO 45050, Reyco (Xiamen) Medical Products Company Limited 308 Wengize Road Hacang Distct XIAMEN, Fujan CHINA 361022 Ccaresream Haat ne, 2000 Howard Smith Averue West Windsor. CO USA 20550 ‘caresream Heath Ine. 1669 Lake Avanue Rochester, NY USA 14652 Name of Product(s) ‘Carestream Brana Fis: EBIRA Film Carestream White Box Brand Fis: Ful Bue Xray Film WE E Blue Xray Film WB Half Blue X-ray Fm Wi ‘Green X-ay Fm WB Green X-ay Fm WS 150 Verona Suest Rochester, NY USA 18608 Name of Manuf resrear Health, ne 126 Pace Ave \WmTE CITY, OR USA 97503, Soluciones Medieas Exportacion S. De RL. De C.. ‘CALLE ANILLO PERIFERICO PONIENTE NO, 3100, COLONIA PARAISOS DEL COLL! ZAPOPAN, Joico MEXICO 45050, Rayco (Xiamen) Medical Products Company Limited 308 Wengjizo Road Hatcang District XIAMEN, Fujan CHINA 961022, ‘py U.S. FOOD & DRUG ‘tousnoarharoaan tienes, co ADMINISTRATION Siver Sping, M0 288 Certificate No. 3838-1.2021 Certificate to Foreign Goverment - Name of Product(s) Attachment Page 2 of 6 Carestream Health, ne 2000 Howard Smith Avenue West ‘Windsor, CO USA 80850 INSIGHT 952 Fim INSIGHT Pectatic Fim INSIGHT Thorace Fim Medical Xray Blue JN Film Medical Xray Blue /NXBE Fin Medial Xray Green XG Fir eR 2000 Pi Fim MIN-R EV Fit MIN-R EA Fim INR § Fil XGA Plus Film MKB IN Fam Oncology EC Fim Oncology EDR2 Firm (Oncology Portal Pac for Localization / PPL. Film Oncology Simulation / SIM Fim HET Film PFA Ps Film PEL Phas Film RA Dupiesting Fim TEMATGIRA Film T-MAT URA Fim XOMAT BT Fim XOMAT HBT Farm XSIGHT GIRA Film MAT DBF Laser imaging Films: ‘TRIMAX TXE Lazer Imaging Film ‘TRIMAX TXN Laeor Imaging Film “TRIMAX TM Lazer Image Film TRIMAX TXE Laser Imaging Film [AERME] AMB* Laser Imaging Fim Non-Laser Media DDRYVIEW CHROMA Medical Fim Name of Owner Operator ‘Caresveam Healt nc. 150 Verona Steet Rochesier, NY USA 14608, Name of Manufacturer Seluconos Medieas Exportacion S. De RL. De C.. CALLE ANILLO PERIFERICO PONIENTE NO. 3100, ‘COLONIA PARAISOS DEL COLL ZAPOPAN, Jalioo MEXICO 45059 ‘Carestream Heat ne. 200 Howara Smith Averua West Windsor, CO USA 20550 Name of Produetis) sina Grand Fis, (gy U.S. FOOD & DRUG Haake entenee ADMINISTRATION ve Spring MD 20883 Lo. eeriasanning os Certificate No. 3838-1-2021 Certificate to Foreign Government - Name of Product(s) Attachment Page 3 of 6 RETINA xy SOE RETINA xy XBE RETINA xy XOE Name of Owner Operator ‘Garesveam Heath, 150 Verona Steet Rochester, NY USA 14608 Name of Manufacturer ‘Carestream Heat nc. 2000 Howard Smith Avenue West ‘Windsor, CO USA 80550 Carestream Health, Ine 1869 Lake Avenue Rochester, NY USA 14852 Name of Product( (Carestream Devsa rand Fis: ee speed E-Spoed eve Insichr TMATE TENAT GIRA EAT URA Utra-speed Name of Owner Operator ‘Caresream Heath, 150 Verona Steet Rochesie, NY USA 14608 Name of Manufacturer Seluciones Medieas Exporacion S. De RL. De CL. ‘CALLE ANILLO PERIFERICO PONIENTE NO. 3100, COLONIA PARAISOS DEL COLL: ZAPOPAN, Jao MEXICO 45059 Carestream Healt ne 1859 Loke Avenu Rochester, NY USA 14852 Name of Product(s) ‘OMAT 2 Dental Duplicating Name of Owner Operator Carestam Health Ine 150 Verona Sweet Rochester, NY USA 14608 Name of Manufacturer Carestream Hoalh In 8124 Pace Ave WHITE CITY, OR USA 97503iy U.S. FOOD & DRUG 15, Food ay Adinistrsbon 0903 Ne Harps Avenue $ ADMINISTRATION eee Certificate No. 3838-1-2021 Certificate to Foreign Government - Name of Product(s) Attachment Page 4 of 6 ‘CARESTREAM HEALTH, INC. {IMATION WAY ‘OAKDALE, MN USA 55128 ‘Soluciones Medicas Expottacion 5. De RL. De GY. CALLE ANILLO PERIFERICO PONIENTE NO. 3100, COLONIA PARAISOS DEL COLL! ZAPOPAN, Jasco MEXICO 45059, ‘Rayco (Xlamen) Mosca! Products Company Limiad 308 Wengiao Road Hsicang Dstt XIAMEN, Fujan CHINA 361022 CCarasream Heat ne 2000 Howard Smith Avenue Wt Windsor, CO USA 80650 Name of Product Ceretream Brand Laser Imaging Fire DDRYVIEW OVB Laser Imaging Film DDRYVIEW DVB Laser Imeging Film [DRYVIEW OVB+ Premium Laser Imaging Film DDRYVIEW DVC Laser acing Fim DDRYVIEW DVCé Laser Imaging Firm [DRYVIEW DVE Laser Imaging Fim DRYVIEW DVM Mammography Lase Imaging Film DDRYVIEW DVM Marnmograpty Laser Imaging Film DRYVIEW OVZ Laser Imaging Fim Name of Manufacturer Carestream Healy, Ine 124 Peete Ave WHITE CITY, OR USA 97503 Solusionas Madicas Exporacion S. De RL. Do CV. CALLE ANILLO PERIFERICO PONIENTE NO. 3100, COLONIA PARAISOS DEL COLL! ZAPOPAN, Jalisco MEXICO 45059 Fayco (Xiamen) Metical Products Company Limited 308 Wengigo Road Haicang Distt XIAMEN, Fujian CHINA 261022 Name of Product(s) ‘Non-Laser Mec: DDRYVIEW CHROMA Medical Paer-Glossy eof Owner Operator Carestream Heath Ine 190 Verona Steet Rochester, NY USA 146508 Name of Manufacturer retream Heath Ine 1048 West Ridge Road Rochester, NY USA 14815fehl U.S. FOOD & DRUG Un ng nr & aaniniavedaieee 08 New iano vn Certificate No. 3838-1-2021 Certificate to Foreign Government - Namo of Product(s) Attachment Page 5 of 6 Name of Product(s) ‘Carestream Brand Screens: LANEX Fast Screens LANEX Measum Sezeens LANEX Regular Screens ‘MIN.R 2000 Screen MIN.R 2190 Serean Paral Imaging Phospher Pte Carestream Dental Brand Screens LANEX Mecium Seveene LANEX Regular Screens XOMATIC Regular Screens ‘Carestream Brand Cassetis wth Screens MN-R 2 Caasete wth MINLR. 2000 Screen MIN-R 2 Cassoto with MINLR. 2100 Sereen MINC-R 2 Cassete with MINLR 2250 Sereen MIN-R 2 Gasset wth MIN-R Sereen ‘Carestveam Brand Photochemical (GBK Developer and Repleisher (GK Far and Repinisher RP X-OMAT Developer and Repleisher RP X-OMAT Developer Starter RP X-OMAT LO Foeer and Replensher XCE Developer and Replerisher OF Fer and Replenisher X-OMAT Developer Starter X-OMAT EX Il Daveloper and Replenisher X-OWATICM D-t Developer and Replenisher X-OMATICM F-1 Foor and Replenishar X-OMAT LE+ Developer and Repinisher X-OMAT LE Fixer ana Replensner X-OMAT NOX Developer and Repenisner X-OMAT NOX Fixer and Replensher XPE Developer XPF Fier Caretroam Donia! rand Photochomicale: ‘CARESTREAM DENTAL Developor CARESTREAM DENTAL Fier CARESTREAM DENTAL X-ray Developer (CARESTREAM DENTAL X~ay Fixer ‘CARESTREAM DENTAL X~ay Monobath (GBX Developer and Replerisher G6BX Fixer and Replenisher (GBK Twin Pack pis Access Developer Reps Access Fier Rep Access Twin Pack READYMATIC Chem Pack READYMATIC Developer and Replenisher READYMATIC Fier and Replenisher READYPRO Twin Pack Medical Analog Cassetes wth Screens:ADMINISTRATION inen ee rernaeee fy u.s. FOOD & DRUG Us fot ra & Certificate No. 3838-1-2021 Certificate to Foreign Government - Name of Product(s) Attachment Page 6 of 6 Select Cassatt wth LANEX Fast Screens Select Cassette with LANEX Medlum Screens ‘Select Cassette wth LANEX Regular Screens END OF PRODUCT LIST-————————