5180692548

5180692548



Version number: A/0

Company Name:

Company Address:

Related Oirectives and Annex

Related Standards Products Name

Product Modcl/Typc

European Authorired Representative:


CERTIFICATE FOR MEDICAL DEVICE Dedaration of Conformity

File Na: HDK-001 -030220



Shandong Haidke Me&cal Products Co..Ud.

Tianfu Road. Dongcheng District. ShanCounty, 274300 Hete Gty. Shandong Prowince, China.

MDD93/42/EEC Medical Domce 0ircc1ive/Annex VII Class I Non Stenie

EN ISO 13485 2016, EN14683:2014, ENISO10993-1, EMSO10993, ENIS010993-10, EN ISOl 1737-1, IS022609, EN 1041:2008. EN ISO 14971:2012

Face Masks

Earloop fiat type: 12.Sx9cm, 14.S»9.Scm, lŁS*9.Sem. 17.5*9.5cm Vertical type: 1/2 0*L 9cm*10cm. 9cmKiicm, 10cmxiicm, 10cm*12cm, llcmxl2cm, llcmxl3cm, ll.5cm*13cnv 12em*13em, 12cmxi4cm. 11.5cmxl5cm

CMC Medical Desrices & Drugs S.I.

Add: C/ Horacio Lengo N« 18. CP 29006, M4laga. Spain Tel: *34 9S1214 0S4 Contact: Manuel Mateos Email: info@cmcmedicaldevices.com


The Products satlsfies the reqt*rements of the above llsted standards. The Manufacturer Is respony We for carrying out all the neccssary actrwitcs, asrequred by the Oircctive.

C €


Add: C/ Horacio Lengo N» 18. CP 29006, Malaga. Spain Tel: *34 9S1 214 054 Email: info@cmcmedicaldewices.com




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