AP MASCARILLAS SA DE CVl6000297.ferozo.com/pdf/COFEPRIS-M10.pdf · AP MASCARILLAS, SA DE CV ....

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Nuevos Horizontes # 3917, Col. Lázaro Cárdenas, Tlalnepantla, Edo. Méx. CP 54189 Tels. (55) 57181075, 53846159, 20625440 y 57184035, email: [email protected] AP MASCARILLAS SA DE CV La Innovación… guardando la Tradición. EQUIPO DE PROTECCION RESPIRATORIA Y, EQUIPO DE PROTECCION INDUSTRIAL www.apmascarillas.com.mx ISO 9001:2015 TO OUR COSTUMER In this document, page 2, you have the English translation of permission granted by the COFEPRIS (Federal Commission for Protection against Health Risks in Mexico), an organization with functions similar to the FDA in Mexico, to use our personal model AP mask -M10, and on page 3 is the original document in Spanish. For more information about COFEPRIS you can consult the following web page: https://www.gob.mx/cofepris/ Dr. Jaime Aguilar Ortiz Project Manager AP MASCARILLAS, SA DE CV

Transcript of AP MASCARILLAS SA DE CVl6000297.ferozo.com/pdf/COFEPRIS-M10.pdf · AP MASCARILLAS, SA DE CV ....

Page 1: AP MASCARILLAS SA DE CVl6000297.ferozo.com/pdf/COFEPRIS-M10.pdf · AP MASCARILLAS, SA DE CV . DOCUMENT TRANSLATION (Top left LOGO OF THE SECRETARIAT OF HEALTH) (Top right COFEPRIS1

Nuevos Horizontes # 3917, Col. Lázaro Cárdenas, Tlalnepantla, Edo. Méx. CP 54189 Tels. (55) 57181075, 53846159, 20625440 y 57184035, email: [email protected]

AP MASCARILLAS SA DE CV La Innovación… guardando la Tradición.

EQUIPO DE PROTECCION RESPIRATORIA Y, EQUIPO DE PROTECCION INDUSTRIAL

www.apmascarillas.com.mx

ISO 9001:2015

TO OUR COSTUMER

In this document, page 2, you have the English translation of permission granted by the COFEPRIS

(Federal Commission for Protection against Health Risks in Mexico), an organization with functions

similar to the FDA in Mexico, to use our personal model AP mask -M10, and on page 3 is the

original document in Spanish.

For more information about COFEPRIS you can consult the following web page:

https://www.gob.mx/cofepris/

Dr. Jaime Aguilar Ortiz Project Manager

AP MASCARILLAS, SA DE CV

Page 2: AP MASCARILLAS SA DE CVl6000297.ferozo.com/pdf/COFEPRIS-M10.pdf · AP MASCARILLAS, SA DE CV . DOCUMENT TRANSLATION (Top left LOGO OF THE SECRETARIAT OF HEALTH) (Top right COFEPRIS1

DOCUMENT TRANSLATION

(Top left LOGO OF THE SECRETARIAT OF HEALTH) (Top right COFEPRIS1 LOGO) OFFICE NO. 163300CO210578 Mexico City on January 12, 2017 In relation to his brief, with entry number 163300CO210578 of September 14, 2016, it is communicated that based on the articles: 4 third paragraph, 8, 14 and 16 of the Political Constitution of the United Mexican States; 39 of the Organic Law of the Federal Public Administration, bis 17, 19 fraction II, 194 bis, 262 and 368, of the General Health Law; 1 and 2 subsection C fraction X of the Internal Regulations of the Ministry of Health; 1, 3 fraction I subsection b, 4 fraction I subsection of the Regulations of the Federal Commission for Protection Against Sanitary Risks; 1 and 154 of the Health Supplies Regulation; Twentieth of the Agreement by which the indicated powers are delegated, in the administrative bodies indicated in it of the Federal Commission for the Protection against Sanitary Risks, published on April 7, 2010 in the Official Gazette of the Federation, they are informed of the following: Regarding your product called: AP M10 Air Purifying Respirator. Mask with an electrostatic filtering medium, used as industrial safety equipment. They are informed that at the moment this product does NOT require a Sanitary Registration in this Sub-department, in case it must be registered later it will be officially notified. Do not avoid mentioning that even when this product does not require a Sanitary Registration, it does not exempt national manufacturers or foreign-made distributors from sanitary control based on article 194 of the General Health Law Section II and 82 of the Health Supplies Regulation. EFFECTIVE SUFFRAGE NOT RE-ELECTION MANAGER OF MEDICAL INSTRUMETAL DIAGNOSTIC AGENTS AND SUPPLIES FOR DENTAL USE (SIGNATURE) JOSÉ ANDRÉS CAMPOS CUEVAS

1 COFEPRIS, Federal Commission for Protection against Health Risks), organization with functions similar to the FDA in Mexico. Web page: https://www.gob.mx/cofepris/

Page 3: AP MASCARILLAS SA DE CVl6000297.ferozo.com/pdf/COFEPRIS-M10.pdf · AP MASCARILLAS, SA DE CV . DOCUMENT TRANSLATION (Top left LOGO OF THE SECRETARIAT OF HEALTH) (Top right COFEPRIS1