FDA 文件
size: 253.22 MB
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|- 生物相容性报告 - 0 B
|- Test Reports (2015115) - 0 B
|- Summary reports-0 - 0 B
|- Medline Safety needle FDA documents SEP 16 - 0 B
|- Medline Drawings PDF - 0 B
|- FDA文件 - 0 B
|- FDA technical drawing - 0 B
|- FDA docs model - 0 B
|- FDA - 0 B
|- BIOCOMPATIBILITY TEST - 0 B
|- 有效期验证注射器带安全注射针(1).zip - 68.00 kB
|- 有效期验证报告.pdf - 6.00 MB
|- 扬州美德莱医疗用品有限公司注射器部分检验报告(英文).doc - 80.00 kB
|- US FDA 510K Safet Needle Configuration List v1.docx - 80.00 kB
|- US FDA 510K Safet Needle Configuration List v1.1.docx - 83.00 kB
|- US FDA 510K Safet Needle Configuration List v1 v1.3.docx - 56.00 kB
|- US FDA 510K Safet Needle Configuration List v1 v1.2.docx - 56.00 kB
|- Transportation Simulation Testing Report .pdf - 2.00 MB
|- Statement of truth and accuracy.jpg - 319.00 kB
|- Product Sterile Test Report 11371-2.pdf - 834.00 kB
|- Product Initial Contaminating Bacteria Test Report 11737-1.pdf - 917.00 kB
|- ISO TESTING Cathy.pdf - 26.80 MB
|- ISO 7864 9626.pdf - 26.80 MB
|- ISO 11607-2_2006 Packaging for terminally sterilized med dev-Part 2-Val reqs for forming, etc.pdf - 181.00 kB
|- ISO 11607-1_2006 Packaging for terminally sterilized med dev-Part 1-Reqs for mtls, etc.pdf - 286.00 kB
|- GMP RS 510(K) MASTER1.pdf - 3.70 MB
|- FDA灭菌.zip - 519.00 kB
|- ECH TEST REPORT SDWH-M201500995-1.Pdf - 2.30 MB
|- DDL Syringe-Needle Testing Report1110201 - Report[1].pdf - 15.50 MB
|- DDL ISO7886-4.docx - 132.00 kB
|- Biocompatibility test report Medline.pdf - 163.40 MB
|- 510K Matrix @ 26.6.15.pdf - 2.80 MB
|- 2013一次性使用无菌注射器 带安全注射针 初包装确认报告.doc - 304.00 kB
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