Test Report Report No.: GZAFN1903003572S009 Date: Apr 01 2019
Client name: Shenzhen UVLED Optical Technology Co., Ltd Client address: 802Room,8F/1B, Techno Industrial Park, Guangming New District, Shenzhen Sample name: UVC LED Toy Sterilizing Bag (SZD12-P18M ) Sample Batch No.: / Product Date: / Manufacturer: / Sample other information: / ------Above sample(s) was/were submitted and certified by the client, SGS quoted the information with no responsibility as to the accuracy, adequacy and/or completeness.
SGS Sample No. GZAFN1903003572S.003 SGS reference No. / Date of sample received: Mar. 12, 2019 Testing period: Mar. 12, 2019 ~ Mar. 29, 2019
TEST(S) REQUESTED: Selected test(s) as requested by the applicant
TEST METHOD(S): Please refer to next page(s)
TEST RESULT(S): Please refer to next page(s)
This test report has been drafted in English and maybe translated into other languages, The English version shall prevail.
SGS-CSTC Standards Technical Services Co., Ltd. Guangzhou Branch
……………………… SGS Authorized Signature 胡楷崎 Catherine Hu
This test report refers only to items tested. This document cannot be used for publicity, without prior written approval of the SGS.
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Test Report Report No.: GZAFN1903003572S009 Date: Apr 01 2019
TEST RESULT(S): Sterilization efficacy evaluation Test Method: With reference to Technical standard for disinfection (2002) Ministry of health of the people’s republic of China, 2.1.5.5 Test Organism(s): Escherichia coli 8099 Concentration Positive Treated Test Killing log Killing rate Test organism of bacteria control A sample B times value (%) (cfu/mL) (cfu/piece) (cfu/piece) 2.2×10 8 3 min 1.1×10 6 2.3×10 2 3.68 99.98 Escherichia coli 2.2×10 8 3 min 1.1×10 6 2.4×10 2 3.66 99.98 8099 2.3×10 8 3 min 1.0×10 6 2.3×10 2 3.64 99.98
Remark: 1.Killing rate= ((A-B)/A) *100%. 2.The test distance was 15.5 cm. 3.The sterilization is carried out in accordance with the instruction of product.
SAMPLE DESCRIPTION :::Equipment
Photo Appendix
SGS authenticate the photo on original report only *** End of Report ***
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Fiscal Year 2018 CERTIFICATION OF REGISTRATION
This certifies that:
SHENZHEN UVLED OPTIC TECHNOLOGY CO.,LTD 8/F,Techno Park,Tongguan Road,Guangming District Shenzhen, Guangdong, 518132, CHINA
has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration, through
Shenzhen CTB Testing Technology Co., Ltd.
Owner/Operator Number: 10058275 Device Listing#: See annex
CTB will confirm that such registration remains effective upon request and presentation of this certificate until the end of the calendar year stated above, unless said registration is terminated after issuance of this certificate. CTB makes no other representations or warranties, nor does this certificate make any representations or warranties to any person or entity other than the named certificate holder, for whose sole benefit it is issued. This certificate does not denote endorsement or approval of the certificate-holder’s device or establishment by the U.S. Food and Drug Administration. CTB assumes no liability to any person or entity in connection with the foregoing. Pursuant to 21 CFR 807.39, “Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding.” The U.S. Food and Drug Administration does not issue a certificate of registration, nor does the U.S. Food and Drug Administration recognize a certificate of registration, CTB is not affiliated with the U.S. Food and Drug Administration.
______Chief engineer Issued: October 11, 2018 Expiration Date: December 31, 2018
Fiscal Year 2018 CERTIFICATION OF REGISTRATION
Annex to Device Listing# for Owner/Operator Number: 10058275
Listing No Code Device Name Proprietary Names Activities UV LED portable sterilizer X1 UV LED Handheld sterilizer X5 UVC LED Sterilizing Box S1, S1-BAT, S2,S2-BAT UVC LED Sterilizing Cup T1 UVC LED Mini Sterilizing
UNIT, ULTRAVIOLET Box S6 UVC LED Phone Sterilizing SANITATION/STERILIZA ponch P8 Manufacturer D327778 TION (FOR NOB UVC LED Sterilizing Foreign TOOTHBRUSHES), Handbag P9 Exporter NON-STERILE UVC LED Toy Sterilizing
Bag P18 UVC LED Muti-Functional Sterilizing Lid S8 UVC LED Round Sterilizing Sticker S9 UVC LED Square Sterilizing Sticker S10 UVC LED Sterilization Mummy Bag P14
END OF THE ANNEX
______Chief engineer Issued: October 11, 2018 Expiration Date: December 31, 2018