VIETNAM RUBBER TECHNOLOGY COMPANY LIMITED ( VRT ) was established on 2014 specialized in manufacturing high-quality condoms and face masks complied with International Quality.
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- Phone: +84 868 031 821
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- Email: [email protected],[email protected].
Viet Nam Rubber Technology Company was established on 2014 specialized in manufacturing high-quality condoms and face masks complied with International Quality. Our goal is to offer to our customers the highest quality products and the most satisfactory experience for safe sex. Our adapted modern Germany manufacturing technology ensures each product meet stringent international standards.
FAD
This certifies that: VIETNAM RUBBER TECHNOLOGY CO., LTD LOT K4, Street 10, Hai Son Industrial Zone (Phase 3+4) Binh Tien 2 Commune, Duc Hoa Ha Ward Duc Hoa Ha District Long An, VN 850000 Is registered with the U.S Food and Drug Administration for FY 2020 pursuant to Title 21, 807 et seq, of the United States Code of Federal Regulations: - Establishment Owner/Operator Number: 10073627 - Device Classification Name: FACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/ HEALTHCARE PERSONNEL PER IIE GUIDANCE - Product code: QKR - Office Correspondent: Registrar Corp - And U.S. Agent: 144 Research Drive, Hampton, Virginia, 23666, USA. Telephone: +1-757-224-0177. Fax: +1-757-224-0179.
CE Declaration
In accordance with the following applicable directives: Directive 93/42/EEC The device, as described herewith, was tested pursuant to applicable test procedure and complies with the requirements of EN 14683:2019 Manufacture: VIETNAM RUBBER TECHNOLOGY CO., LTD Product: Medical Face Mask EU Representative: CMC Medical Devices & Drugs S.L. C/ Horacio Lengo N18, CP 29006, Málaga-Spain [email protected] Classification - Annex IX: Class I, Rule 1 Router of Compliance: Annex VII
BIS
This is to certify that VIETNAM RUBBER TECHNOLOGY CO., LTD., LOT K4, Street 10, Hai Son Industrial Zone (Phase 3+4) Binh Tien 2 Commune, Duc Hoa Ha Ward Duc Hoa Ha District, Long An Province, Vietnam. as complete the certification audit of Quality Management System according to ISO 13485: 2016 & EN ISO 13485:2016 for the scope of: The manufacture of non-sterile male latex condoms and medical face mask. The audit was conducted by BSI Vietnam on June 12, 2020, our audit team has concluded that basically all requirements of ISO 13485:2016 are fufilled. The relevant documents were forwarded to the Certification Department of BIS Group for final approval and issuing the certificate.
Business Type | Manufacturer |
Company | VIETNAM RUBBER TECHNOLOGY COMPANY LIMITED (VRT) |
Main Products | ASTM Level 3 Surgical Masks, face masks, sterile face mask |
Website | https://level3surgicalmasks.com/ |
Established Year | 2014 |
City / State | Ho Chi Minh , Ho Chi Minh |
Country | Vietnam |
Address | 112 Tran Hung Dao Str., Pham Ngu Lao Ward, District 1 |
Location | Lot K4, Street No. 10, Hai Son Industrial Zone (Phase 3+4), Binh Tien 2 Commune, Duc Hoa Ha Ward, Duc Hoa District, Long An Province 82724, Vietnam |
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Number of Production Lines | 4 |
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