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普迈德多项产品荣获CE新法规IVDR认证证书

普迈德（北京）科技有限公司自主研发的多项产品荣获由德国卫生部（German Institute of Medical Documentation and Info）签发的欧盟IVDR CE认证证书，产品包括血栓弹力图仪、荧光免疫层析分析仪、胶体金免疫层析分析仪及核酸提取试剂等，强有力的证明了普迈德产品获得了高度认可。

“CE”标志是一种安全认证标志，被视为打开并进入欧洲市场的护照。IVDR欧盟体外诊断医疗器械法规（EU 2017/746），于2017年5月5日正式颁布，并于同年5月25日起生效，自2022年5月26日起，将全面实施新法规，在法规层级上将原先的指令上升为法规。这些法规的颁布表明欧盟市场对医疗设备领域监管的进一步重视。目前正处于IVDD到IVDR的过渡阶段，普迈德也走在行业前端，率先拿到IVDR的证书，顺利打开欧盟大门。

同时，已有34个项目获得了IVDD的CE认证，产品如下

1	Platelet Mapping AA Kit
2	Platelet Mapping ADP Kit
3	Platelet Mapping ADP & AA Kit
4	Thrombelastograph Heparinase Cup Kit
5	Thrombelastograph General Cup Kit
6	Rapid Thrombelastograph Kit
7	Adenovirus IgM Antibody Rapid Test
8	Coxsackievirus IgM Antibody Rapid Test
9	Respiratory Syncytial Virus IgM Antibody Rapid Test
10	Influenza A Virus IgM Antibody, Influenza B Virus IgM Antibody and Parainfluenza Virus IgM Antibody Combined Rapid Test
11	Influenza A virus and Influenza B Virus Antigen CombinedRapid Test
12	Mycoplasma Pneumoniae IgG antibody and IgM Antibody Rapid Test
13	B-type natriuretic Rapid Test
14	C Reactive Protein (hs-CRP+CRP) Rapid Test
15	cTnI Rapid Test
16	D-Dimer Rapid Test
17	Ferritin Rapid Test
18	Gastrin-17 Rapid Test
19	β-hCG Rapid Test
20	Helicobacter Pylori IgG Antibody Rapid Test
21	NT-proBNP Rapid Test
22	Procalcitonin Rapid Test
23	Pepsinogen I, Pepsinogen II Rapid Test
24	Serum Amyloid A Protein Rapid Test
25	Serum Amyloid A Protein/C Reactive Protein (hs-CRP+CRP) Rapid Test
26	cTnI/Myo/CK-MB Rapid Test
27	ST2/NT-proBNP Rapid Test
28	ST2 Rapid Test
29	25-OH Vitamin D Rapid Test
30	COVID-19 Antigen Rapid Detection Kit (Colloidal Gold)
31	COVID-19 Neutralizing Antibody Rapid Detection Kit (Colloidal Gold)
32	COVID-19 IgM/IgG Antibody Rapid Detection Kit (Colloidal Gold)
33	Influenza A+B and COVID-19 Antigen Combo Rapid Detection Kit (Colloidal Gold)
34	COVID-19 and COVID-19 Mutant Strain (B.1.1.7 Strain) Antigen Rapid Detection Kit (Colloidal Gold)