BAN DICH | TRANSLATION | NAM TAI CHINH 2023 GIAY CHUNG NHAN DANG KY VAN BAN NAY CHUNG NHAN RANG: TONG CONG TY CO PHAN Y TE DANAMECO Bja chi: $6 12, durdng Trinh Céng Son, Hda Cudng Nam, Quén Hai Chau, Thanh phé Ba Ning, $50000, VIET NAM, Ba hoan thank vige Bang ky thanh lap FDA (v6i tw cdch la nha san xudt, nha san xudt theo hyp déng) va Dank sach thiét bj vdi Cuc quan lf Thyc phim & Duge phim Hoa Kj. THANH LAP: “Tensor STIR MAY SAN RUAT VAT TOY TE QUANG NAN ~ CHI NANT TONG CONG TY COPTANY TE DANAVIECO Dia Con Ci Tit WAZ. Xa Da Hn. Ty a4 Dn Bn, Th Qing Na STATS. VIET NANE Shay SORT BUNS SST CHU SO HUU/NHA DIEU HANH: Cea TONG CONGTY COHAN TEBANANECO Disc S12, dtg Tih Cig So, Hn Cte Nm, Qo Ha CT GH Nl, SO, VTET NAT Sia Sas a TOTS ami Dani sich sb | ~Misin phim | Tea ie [“Renicania J Toa CHI TIET XEM TAL DINH KEM PHY LUC A J ‘TPS xéc nbn ring vige dang ky nay vin 6 higu ye theo yéu eu va xudt tinh gy chime nhfn nay cho dn cub nim dong ich niéu trén,trirkhi vige dang ky néi trén bi chém dit sau khi ep gidy ching nbgn nay. TPS eding nhu chime nhén nay khéng dua ra bit ky tuyén bé hay bio dim nao cho bat ky e4 nhan hoge t6 chire nao ngoai chi sé hitu 66 tén 6 trén, theo loi ich duy nhat duge dp chimg nhan. Gidy chimg nhin nay khéng biéu thj su chimg thurc hod phé duyét sy thanh lép cia ngudi gitr gidy ching nhan bei Cuc Quan ly Thye phim va Duge phim Hoa Kj. TPS khéng chiu tréch nhiém php ly d4i v6i bat ky ca nhin hode t6 chire nao lién quan dén nhitng digu d& n6i 6 tren, Can cir theo 21 CFR 807, "Vige dang ky thiét lép thiét bi gin sé dang ky khéng biéu thi su chp thugn cia co sé hoe céc sin pham ca co s6 theo bat ky cach nao, Bat ky tuyén bé nao vé sur chip thufin chinh thie déu c6 thé gay hiéu nham va edu thanh han higu gia". Cue Quan ly Thue phim va Duge phim Hoa Ky khéng cép gidy chimg nhén dang ky, cling khéng céng nhén gidy chimg nhan ding ky. TPS khéng truc thude voi Cuc Quan ly Thye pham va Duge phim Hoa Ky (Dit ky va dong déw) Clip lin thie Natha Nguyen on12023 Chit kf c6 thiim quyén tgi Vigt Namim, CCCD s6; 001183066877 do Cue cdnh sat quan Iy hinh chinh gay 27/09/2022: eam doan dich chinh xée gidy to/ vin ban nay tr tiéng Anh sang tiéng Viét. NGUOI DICH Phi Thi Hai LOI CHUNG CUA CONG CHUNG VIEN Hom nay, ngay 10 thang 01 nam 2023 (Ngdy mudi , thang mét, nam hai nehin khong ‘tram hai mugi ba) Tai Van phong céng chig Tran Quang Sang; dia chi tai: phuéng Giang Vo, quan Ba Dinh, thanh phd Ha Noi. Toi, Neuyén Van Thu, céng ching vién, trong pham vi trach nhigm cia minh theo quy dinh eiia php luat 86 315, pho Kim Ma, ‘CHUNG NHAN: - Ban dich nay do ba Phi Thj Hai Sim, CCCD s6: 001183066877 do Cyc canh sat {PO quan ly hanh chinh vé trat ty xa hdi cép ngay 27/09/202: tte phéng céng chimg Tran Quang Sang, thanh phé Ha Noi da dich tir tiéng Anh sang tiéng _ ~ Chir ky trong ban djch duing la chit ky cia ba Phi Thi Hai Sam; —< ~NOi dung ban dich chinh xéc, khong vi pham php lu, khéng tri dao de xa hy u - Van ban cng chimg nay duge Ip thanh 05 (nam) ban chinh, méi ban g6m_ 02 ta, 02 trang, liu 01 ban tai Van phong céng ching Tran Quang Sang, thanh phd Ha NGi Sé cng chimg Quy 1/2023TP/CC-SCC/BD. 000216FISCAL YEAR 2023 CERTIFICATE OF REGISTRATION THIS CERTIFIES THAT: DANAMECO MEDICAL JOINT STOCK CORPORATION Office: No 12, Trinh Cong Son Street, Hoa Cuong Nam, Hai Chau District, Da Nang City, 550000, VIETNAM. Has completed the FDA Establishment Registration (as manufacturer, contract manufacturer) and Device Listing with U.S. Food & Drug Administration. ESTABLISHMENT: Fit Warne {QUANG NAM MEDICAL DEVICES FACTORY BRANCH OF DAMAMECO MEDICAL JOINT STOCK CORPORATION Adress Trang Nhat 2 Industrial Zone, Dien Hea Commune, Dian Ban Tovin, Quang Nam Province, $3815, VIETNA Registration Number 3016570619 DUNS Number 555297766 OWNER/OPERATOR: " DAMAMECO MEDICAL 3OIIT STOCK CORPORATION ne 12 Trinh Cong Son Street, Hos Cuong Nam, Hal Chew District, Da Nang City, 350000, VIETNAM soo7isae DETAILS IN THE ATTACHED APPENDIX A ‘TPS will confirm that such registration remains effective upon request and presentation ofthis certificate until calendar year stated above, unless said registration is terminated after issuance of this certfcate. TPS makes no other representation or warranties, nr does this certifcate makes any representations or warranties to any person of entity other than the named certifiate holder, for whose sole benefit it is issued. This certificate does not denote endorsement or approval of the certificate-holder’s device of establishment by the US. Food and Drug Adminitration, TPS assumes no liability ‘to any person or entity in connection withthe foregoing, Pursuant to 21 CFR 807, “Registration ofa device establishment of assignment ofa registration number does not in any way denote approval of the establishment or its products; Aay representation that creates an impression of offcial approval because of registration or possession ofa leading and constitutes misbrandipg”. The US. Food and Drug Adminitration does not issue 3/4 X a certificate of registration, TPS is 9p IBAN DICH TRANSLATION NAM TAI CHINH 2023 PHY LUC A~DANH SACH CHI TIET THIET B] SAN PHAM Sb chit so hiru/nha diéu hah: 10071934 86 ding ky: 3016970619 SIF | Soni Minste r Ten hit 2 2 7 eget lta it bi Ten age gue ai 7 IRR tang pb nt ne paesiss | rox | Khu ang pho De a Z| Ae | ME [Ga icing Ding MTG VTE Die 3._| “peamsa0 | GY —| Guess, dng xm anip vio wo Ein guang Diane a "Khlong yf eo chink sch hus 8 vr Kil rang y © VaR = : DEST | OKR | ang mites wong wuinghop wren bb nh rang Khia dp y Beng ag_| D-H Tammy Face Cre S| Baw6709 | HSA hi wang mtn nb wang pu tlt ‘Care Tami Face Care 6] 6396713] YO | Phy if, rang phe pul D.Gar, Tammy Face Care 7_[ 0398759 | FXO | “Trang phe y 8, pu thud ‘DCore; Tammy Face Care |“ B398761 | GEA | ho ehoang cash Ting plu at ‘DiGare, Tammy Face Care 3] Dios — | RHA | Mina to Die 10_|bos040 | Fx? | Boe wis wy dina wens pone PR a Dive Ti] baosoat—| BWP] Giay va be gly, 0 a dln DiGare T2_| bvos0e5 | FW | Gity ding wong pine pl tu Dice 13 beB0695 | KXF | Thr hn dng, im hi og RRS Tht chap dong thn Danae Ta| ~DiR0655 | — FRL | Bg. yim at Bong ie Danareco 15 | pease | wan | caciméng as, king hip bu, ing gol de Seplies ev tes ip tm. ding set 7 i ‘Mo pl od i ing a Dace, eeterace ee | ena ‘Ma pha thlt Dacameco (Cham du) TBs | WW [Tach my pa Nw Dare 13_|Des117 | BYY | Kh of ni, Ding mit in DGare 19_[Daaeris | — HT] Kin potato nn Die 30._|Dadsiz2 | ~ OFX | hin phi cco iu Ho ching hin ng yea DiGi Z| butsi23_[~FOM | Bang thu, co din Dicue 3a_|DaWsTa0— | PUT | hn, po mia Diwe Bi | baasizi | RGT | Khan ip Kh wp th Oo. eO Dare 34_[Diisiis | ~ GEC | Bin oh, Trane pe yi ding rong pong pl a Dia 25 | Daagi26 | EFN | Beng, eudn Dicare oe 36_|Deesri6 | EYX | Rhin piu dai Tin waco tanga Dee “ 2r_[ teeta | — NR | mi, Mid din, Ham ng, Bg tin sip, Kg KE DiGi 35_[ “Deena | FYE | Gud do. pt Dive a a Dicue 30 [beget | FME | ho po thd Thi him ben Dita 31_[DHB135 | MW | Gib do, hin Dita S| ease? [ERY | hin ph hak a og Dire 33_|_ Deawses | NEC | Bins thn, dire dich, an phn Bo veda Due (Da by va déng ddu) Cap lin thie $ Natha Nguyen owr2023 (Chie bj: c6 thiim quyén tai Vigt Nam — ee — ] e Ss www.ce-fda.ora irSam, CCCD s6: 001183066877 do Cue cdnh sat quan Iy hanh chinh u ngay 27/09/2022; cam doan dich chinh xéc gidy t6/ van ban nay tir tiéng Anh sang tiéng Viét. NGUOI DICH Cor Phi Thj Hai Sim LOI CHUNG CUA CONG CHUNG VIEN Hom nay, ngay 10 thang 01 nam 2023 (Neay mudi , thing mot, nim hai nghin khéng ‘rim hai mugi ba) ‘Tai Van phong céng chimg Tran Quang Sang; dia chi tai: $6 315, phd Kim Ma, phuong Giang V6, quan Ba Dinh, thanh ph Ha Noi. Toi, Neuyén Van Thu, edng chimg vién, trong pham vi tréch nhiém ciia minh theo quy dinh cua phap luat : iy CHUNG NHAN: es 1 PHoy ~ Ban dich nay do ba Phi Thj Hai Sam, CCCD s6: 001183066877 do Cuc canh sit Ch quan ly hanh chinh vé trat ty xa hoi cap ngay 27/09/2022, la cong tac vién phién dich cia Van “AN sy phong céng chimg Tran Quang Sang, thanh phé Ha Noi d& dich tr tiéng Anh sang tiéng Viet. ~ Chit ky trong ban dich duing la chtr ky ca ba Phi Thi Hai Sam; - Noi dung ban djch chinh xée, khong vi pham php luat, khong trai dao dite xa hoi; ~ Van ban eéng ching nay duge lp thanh 05 (nam) ban chinh, méi ban gdm 02 16, 02 trang, luru 01 ban tai Van phong cong cl A i Sé cong chimg Quy 000216 CONG CHUNG VIEN 01/2023TP/CC-SCC/BD.th) risch WA, 2023 APPENDIX A - DETAILS PRODUCT DEVICE LISTINGS Registration Number: 3016970619 ‘Owner/Operator Number: 10071934 ak, sil Being, Dapesabe Ned Gauelsponge, ree, xray aeaable | Dare Face Mes PerErcerent Poy Fx Face VasisArdRespanrs Burg The Decco | O-Care Tammy Fade Care bie heath Bergen Resp, srg B.See; Tammy Fae Ge Teresi Dp Gre Tany Fe Care Sut eral cr Tammy Fae Coe ansurpealnatongoare | bear, TenanFae one as, covering cae oe, Se, opera Dare Soe andthe cove, concn Der Shoes, operant Deve spit, sorbet pel, ton le | beens Frise Tose api Fb rete, aeoert Daranes Heal aot oe Cauesponge neste or eerie use| Baume Hore Senses Rese Spa Sop, seat Danane Stal Cp (toad Cove | Drape, Microscope, Ophthalmic i D-Care ‘Drape, Urological, Disposable “Ek | D-Care. ‘Drape, Patient, Opfithalmic. & [pare ‘Foot Wrap For Tfeatng Restless Leg. ‘Syndrome Symptoms pcre Eercoge, Ease Doe, Sue) Een rape adhesive, Aro ris, Sr, Opreng Roo Cet, Rl : — Drape, Pre Laos Ses, With SF aang mere Finger Cot Cashen, Fe, Derae, War Tiprapried Gaon verte Cou Des, Sail Tape An bandage ave f [sieisieie! s | m podelelyle]