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    20 views9 pages

    1. Khẩu Trang Song Thiên

    Uploaded by

    Thư YJs

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
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    BO Y TE VIET NAM CONG HOA XA HOL CHU NGI VIET NAM Dée lip - Ty do - Hanh phic VIET NAM MINISTRY OF HEALTH SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness Ha Noi, date 29nonth Ofear 2020 GIAY CHUNG NHAN LUU HANH TY’ DO CERTIFICATE OF FREE SALES 1. Gifly chirng nhan s6/Certificate No: 20000041 CFS/BYT-TB-CT 2. San phéim/Product(s): Khdu trang y t¢ UV Mask / Medical mask UV Mask 3. Chiing logi/Model: ST-3L (3 lop); ST-4L (4 Iép) 4. Céng ty so hiru hyp phap: CONG TY TNHH SAN XUAT THUONG MAI SONG THIEN - Product(s) Owner: SONG THIEN TRADING PRODUCTION COMPANY LIMITED - Dia chi: 67/18 Tran Van Ky, Phuéng 14, Quin Binh Thanh, Phudng 14, Quin Binh Thanh, Thanh phd H6 Chi Minh = Address : No 67/18 Tran Van Ky , 14 Ward, Binh Thanh Dist, Ho Chi Minh City, Viet Nam 5. Céng ty sin xudit: Cong Ty TNHH San Xuit Va Thuong Mai Song Thién - Manufacturer: SONG THIEN TRADING PRODUCTION COMPANY LIMITED - Dia chi: 146/20/2 Duong s6 8, Phuong 11, Quin Gd Vap, Thanh phé H6 Chi Minh, Phuong 11, Quan Go Vap, Thanh pho H6 Chi Minh ~ Address: 146/20/2 No 8 Street, 11 Ward, Go Vap Dist, Ho Chi Minh City, Viet Nam. Van ban nay la dé xac nhdn ring céc sin phdm trén tun theo cae tiéu chudin lién quan cua Viet Nam hode tuong durong va durge phép ban tai Viét Nam. Viée xuit khdu san phim khéng bi han ché. This is to certify that the above product(s) comply with the relevant standards of the S.R. Vietnam or equivalent and are allowed to be sold in Vietnam, The exportation of the product(s) is not restricted Gidy chimg nhan nay c6 higu lye 03 ndm ké tir ngay ky. This certificate is vaild for three years from the date of issuance. KT. BO TRUONG THE TRUONG FOR MINISTER OF HEALTH DEPLEXMINISTER OF HEALTH ISOCERT INTERNATIONAL INSPECTION AND CERTIFICATION BODY “HARMONIZATION AND PROSPERITY" CERTIFICATE No. 1869293400445-MED THIS IS TO CERTIFY THAT THE QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES OF: SONG THIEN TRADING PRODUCTION COMPANY LIMITED Office: No. 67/18 Tran Van Ky Street, Ward 14, Binh Thanh District, Ho Chi Minh City, Vietnam. Factory: No, 146/20/2 Street 8, Ward 11, Go Vap District, Ho Chi Minh City, Vietnam. 2016 Has been assessed and found to conform with the requirements of the following standard: ISO 18485:2016 SCOPE CERTIFIED: 1. Manufacturing and trading of medical masks; 2. Trading in medical equipment type B, C, D and medical testing chemicals - equipment. Certification + L1.Mar.2020 Issue date : 11.Mar.2020 Valid date 10.Mar.2023 Details in decision no. 11032003/QD-ISOCERT Approved (o bear certification mark CERTIFICATE ISO 13485 180 18485:2016 (Check the val ofthe cena: epesgcert.ong mn ISOCERT INTERNATIONAL CERTIFICATION AND INSPECTION JOINT STOCK COMPANY 'Nod0 A Row, Block 12, Dinh Cong New Urtan Ares, Dinh Cong Ward, Hoang Mii District, Hanoi City Hotiee: 1900636 38, Han office: 02473. 036.538, HM office: 02873 86.53, Email: contactnocert.og vn, Website tps/Tsocer.rg.m TO CHUC CHUNG NHAN VA GLim DINK QUOe TE ISOCERT “HALHOA CUNG THINH VUQNG” GIAY CHUNG NHAN S6 1869293400445-MED CHUNG NHAN HE THONG QUAN LY CHAT LUGQNG CHO LINH VYC TRANG THIET BI Y TE CUA: CONG TY TNHH SAN KUAT THUONG MAI SONG THIEN Van pl 67/18 Trin Van Ky, Phudmg 14, Quan Binh Thanh, Thanh phd Hd Chi Minh, Vigt Nam. Nha xudng: 146/202 Duing sé 8, Phuimg 11, Quin Gd Vip, Thanh phd Hd Chi Minh, Vigt Nam. 2016 Duge danh gid va xée nhén phit hop vi yéu cu eda tidu chun: Tiév CHUAN ISO 18485:2016 PHAM WI CHUNG NHAN: 1, San xudt va kinh doanh khdu trang y té; AN ISO 13485 = 2. Kinh doanh trang thiét bj y té loai B, C, D va héa chit - thiét bj =S xét nghigm y té. S&S Ngay ching nhgin 11/03/2020 Negay phit hank + 11/03/2020 t Ngay hét han : 10/03/2023 - Chi tiét tai quyét djnh sé: 11032003/QD-ISOCERT i) Dov ryan a hen aha = 4 [=] mipeeee wengacee 150 13085:2016 nevavarial “Tract itu ne ching hi bpisocer.org.vn CONG TY CO PHAN CHUNG HHAN VA GIAM BINH QuOc TE ISOCERT 4-40 diy A. 1b 12 KDT mdi Dich Cong. Phuimg Dinh Céng. Quin Hoding Mai, Thanh phd Hi NOi Hating 190636538, VPIN: 02473036538, VPICM 2873.06 538, Ema comatsisoe orn, Webi hp sce og {8 CASE 1/1 -M418085992 ‘SO KHOA HOC VA CONG NGHETR.HO CHI MINH TRUNG TAM DICH VU PHAN TICH THI NGHIEM TP. HO CHI MINH CENTER OF ANALYTICAL SERVICES AND EXPERIMENTATION HOMC Bese [vmcerrs | 147 | Ma sé mw Sample Code (i biontna KETQUATHUNGHIEM | sueotcn. sane, MMI8085992 TEST REPORT | Tén khéch hing/ Customer CONG TY TNH SAN XUAT THUONG MAI SONG THIEN Dja chi/ Address 67/18 TRAN VAN KY - PHUONG 14 - QUAN BINH THANH - THANH PHO HO CHI MINH Tén mw Name of sample KHAU TRANG Y TE SONG THIEN 6 lugng/ Quantity i Tinh trang mw Sample description : Khu trang Ngay nh§n miw/ Date of receiving 29/08/2018 ‘Ngay hen tra KH/ Date of issue 07/09/2018 ST | Chitiéukiém nghifm/ | Don vj tinh/ Ket qual Result Phuong phip/ No Parameters Unit Test method 1 As mg/Kg Khéng phat hign, CASE.IN.0105 (Ref MDL= 0,02 TCYN 8389-1:2010) 2 ca mg/Kg Khéng phat hign, CASE. IN.0105 (Ref MDL = 0,1 ‘TCVN 8389-1:2010) 3 Hg mg/Kg KhOng phat hién, CASE.TN.0105 (Ref MDL = 0,01 TCVN 8389-1:2010) 4 Pb mg/Kg Khéng phat hién, CASE.TN.0105 (Ref MDL=1 ‘TCVN 8389-1:2010) 5 Sb myKg Khong phat hién, CASE.TN.0105 (Ref MDL= 0,02 TCVN 8389-1:2010) o Phuong phip duge VILAS cng ahin/ Method ls acoredivared by VILAS (9) Két qua duge thye hign boi nha thu phy / Subcontracted sest. MDL - Neutmg phat hign cia phuong phip / Method Detection Limit, Phy trich phong thir nghiém/ Officer in charge of laboratory na auipongc srg argantandaCan Taryn PT TAC KT.GIAM DOC/ PP.DIRECTOR PHO GIAM DOC/ VICE DIRECTOR Lé Thanh Tho SOYTETPHOCHiMINH CONG HOA XA HOLCHU NGHIA VIETNAM Doe lip - Ty do - Hanh phic $6: 200000519/PCBA-HCM Tp Hé Chi Minh, mgay 01 thing 04 nism 2020 PHIEU TIEP NHAN 13 so céng b6 tu chun dp dyng cia trang thige bj y 4 thugelogi A 1. Tén ca ser edng bé: CONG TY TNHH SAN XUAT THUONG MAI SONG THIEN 2. Dia chi: 67/18 Trin Van Ky, Phung 14, Quan Binh Thenh, Phuring 14, Quin Binh Than, Thanh pho HC 3.:S6 van ban 48 nghj eta eo sd: 02/2020/ST Neay: 30/03) 4. Trang thiét bi y thude loai A Ten trang tide by é: Khu tang y t€ UV Mask Ching logim sin phim: ST-3L (3 lip); ST-4L (4 lip) Tén cose si nuit: cdg ty TNHH sn xuitthuong mai Song Thign Dia chi eo s6 sin xudt: 146/20/2 Dudmg s6 8, Phuémg 11, Quin Gd Vap, thanh phé Hé Chi Minh Titu chun ép dung: TCCS 01:2020:8T 5, Thm tin v8 chi sw trang. thit bj y = ‘Ten chi situ: cng ty TNHH sin xuitthuong mai Song Thign Dia chi chi se hit: 67/18 Tein Van Ky, Phutmg 14, Quin Binh Thenb,thinh phd H6 Chi Minh 6, Thong tin v8 ea si bo hn: 7. Thanh phi ho so: 1 [Phu luc chi tidt wang thigt bi yt 2_[ Bin phn loa trang thie biy © 3 | Gily ching alin dar eu chan quan Wy chat Regng cba Higa Tue wr Uno didm Hop Ho 3a 4 | Gidy ay quyn cua chu scr hina trang thigt bi y 3 | Gidy xe nbn da dig ign bio hanh © | Tailigu mw cm cp thade TTBYT theo miu 38 1 Phu luc 8 7_| Gily chimg akin hop chun hoe Ban teu chulin ma chi so hu trang thigt bi y cong ap dung 8 | Tai ligu hudng din sir dung cha trang thidt bj y & 9 | Miu niin s@ sit dung khi wu han tai Vigt Nam cua trang thiét bj y té To] Gity chang vgn haa hinh jw dp cn higy lve Gi thoi Gin pop ho vo Gor yor tang Tet biy 16 nhip kha hose Phieu igp nha ho so cdng bo di digu kign sin xust rang thigt biy 146i v6i TTBYT san xuat trong muse NGUOI TIEP NHAN HO SO Sb: Pam Ta Tha Ree abort ao. 86 Y TE TP HO CHi MINH CONG HOA XA HOI CHU NGHIA VIET NAM. Dge lip - Ty do - Hanh phite ‘So: 200000020/PCBSX-HCM Tp Ho Chi Minh, ngdy 23 thang 03 nim 2020 PHIEU TIEP NHAN Hé so cong bé dit diéu kign san xuat trang thiét bi y té 1. Tén co so cdng bé: CONG TY TNHH SAN XUAT THUONG MAI SONG THIEN 2. Bia chi: 67/18 Trin Van Ky, Phung 14, Quin Binh Thanh, Phung 14, Quin Binh Thanh, ‘Thanh phé Hé Chi Minh (San xuit tgi: Cong ty TNHH sin xuat thurong mai Song Thién: Phurimg 14, Quan Binh Thanh, Thanh phé H6 Chi Minh) 3. Dign thoai: 0862728114 Fax: 4.86 ia chi: 67/18 Tran Van Ky, in ban dé nghj cua eo so: 01/2020/CB-ST Ngay: 16/03/2020 5. Tén trang thiét bi y té co so cong bo san xuat: Khau trang y té 6. Thanh phan hé so: 1 | Van ban phan céng, bé nhiém ngudi phy trich chuyén mén cia co sé sin xudit x 2. | Ban xéc mhan thai gian cing tae x 3 | Vin bing, chimg chi dio tao vé ky thuft thigt by y t€ howe quan ly thigi bi y tcua | ngudi phy trich chuyén mon 4 | Van ban céng bé du diéu kign san xuat x 5. | Ban ké khai nhan su x 6 | Van ban phan cdng, bé nhiém ngudi phy trach chuyén mOn cua co sé san xudt x 7 | Gidy chimg nhan dat tiéu chuan quan Iy chat lugng x 8. | HO so vé thigt bi va quy trin sin xuat, kiém tra chat Iugng pha hep voi yeu cau x cia Jogi trang thiet bi té ma co’ s6 san xuat NGUOI TIEP NHAN HO SO Ky boi: Pham Thj Thanh Hiyen Email ptlhuyen-syt@tphem gov Co.quan: S@ ¥ té, Thin pho le Chi Mink 33-2020 Pham Thi Thanh Huyén (CONG HOA XA HOL CHU NGHIA VIET NAM Déc lip - Ty do - Hanh phic SOY TE TP HO CHi M Sé :170000275/PCBMB-HCM Tp Hé Chi Minh, ngay 17 thang 07 ném 2017 PHIEU TIEP NHAN HO so cong bé dit diéu kign mua ban trang thiét bi y té 1. Tén co so mua bin; CONG TY TNHH SX TM SONG THIEN 2.Dia chi: 67/18 Trin Van Ky, Phung 14, Quin Binh Thanh, Phudmg 14, Quén Binh Thanh, ‘Thanh pho HO Chi Minh 3. $6 van ban d8 nghj eiia ev sé

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