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Why Can We Always Ensure Excellent Quality

Quality Control

Excellent Certifications and Qualifications

• Buda-U is the USA FDA EUA Authorized Respirator Manufacturer;

FDA Device Listed and Registration.

• In China CCCMHPIE White List.

• Buda-U FFP2, FFP3 Protective Masks have got the CE certification by Spanish NB CE 0370 ( Module B+C2 certification)

• 3ply Disposable Medical/Surgical Masks for both Children and Adults have conducted the Attestation of Conformity and meet all the requirements of the EU medical standard of EN 14683: 2019+ AC 2019, and are in conformity with the new provisions of MDR Regulations.

Quality Control: Every Single Piece of Mask to Be Checked.

Buda-U Implements 6S Management and Total Quality Management During the Service & Production Process, in Which Strict Policies & Procedures are Applied.

The filtration efficiency of a mask is crucially important for its quality, while the meltblown fabric work as the filtering materials which are key for a mask's filtration. In this sense, Buda-U has strict policies aiming at controlling the quality of meltblown fabric. We do testing of the materials for every batch of the materials to assure they meet up the required mask standard.

During mask production process , the earloops for every single piece of mask are required to be checked to assure they are firm enough.

PURIFA Medical Production Co.,Ltd

Buda-U Products , Help Fight Against Covid-19, with and for the People Across the Globe.

Buda-U trademark has been registered not only in China, but also in the U.S. and EU in order to echo its global marketing expansion. There has been a significant increase of sales in the EU and U.S. over recent years. Buda-U's products can be easily seen in the market in many countries. And we are establishing distribution channels with our buyers and clients across the world.

We are doing everything that we can to ensure good product quality. Buda-U team is committed to consistently achieving customer satisfaction by delivering best-value products through efficient practice of internal quality management. Buda-U's mission is to consistently provide reliable products that can deliver value to customers in health care and protection.

Certification

PURIFA Medical Production Co.,Ltd Certifications
Standard: CE 0370 Module B Certificate - 2 of 2, FFP2 NR, EU Countries
Issued By: Applus Spain
PURIFA Medical Production Co.,Ltd Certifications
Standard: CE 0370 Module C2 Certificate - 1 of 2 FFP2 NR
Issued By: Applus Spain
PURIFA Medical Production Co.,Ltd Certifications
Standard: CE 0370 Module B Certificate - 1 of 2, FFP2 NR
Issued By: Applus Spain
PURIFA Medical Production Co.,Ltd Certifications
Standard: CE 0370 Module C2 Certificate - 2 of 2, FFP2 NR
Issued By: Applus Spain
PURIFA Medical Production Co.,Ltd Certifications
Standard: CE 0370 Module B Certificate - 1 of 2, FFP3
Issued By: Applus Spain
PURIFA Medical Production Co.,Ltd Certifications
Standard: CE 0370 Module B Certificate - 2 of 2, FFP3 Face Mask
Issued By: Applus Spain
PURIFA Medical Production Co.,Ltd Certifications
Standard: CE 0370 Module C2 Certificate - 1 of 2, FFP3 Protective Mask
Issued By: Applus Spain
PURIFA Medical Production Co.,Ltd Certifications
Standard: CE 0370 Module C2 Certificate - 2 of 2, FFP3 Face Mask
Issued By: Applus Spain
PURIFA Medical Production Co.,Ltd Certifications
Standard: China CCCMHPIE White List, Both Medical & Non-Medical Products
PURIFA Medical Production Co.,Ltd Certifications
Standard: USA EUA Authorizaion Letter - 1 of 2, KN95 Facepiece Respirator, FFP2 Face Mask
Issued By: USA FDA
PURIFA Medical Production Co.,Ltd Certifications
Standard: USA FDA Registration - 2 of 2, KN95 Protective Mask, FFP2 Filtering Half Mask
Issued By: USA FDA
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