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Providing quality products and service for over 40 years

B. Braun Medical Inc. acknowledges that, to be truly competitive in today’s market, it must have a quality system that governs all phases of business operations in order to guarantee its customers that they will consistently receive the quality products and service that they expect.

B. Braun has instituted a quality management system that complies with the requirements of ISO 13485:2016, EN ISO 13485:2016, 21 CFR Parts 820, 210, 211, the Medical Device Directives 93/42/EEC and 2007/47/EC (MDD), MHLW/PMDA and the Canadian Medical Device Regulations, as well as to create an environment conducive to continuous improvement in all aspects of the company.

Related Documents

Description Document Link
PA EN ISO 13485:2016, Certificate No Q5 044904 0046, Rev 01 – Exp 2025-10-25
pdf (317.1 KB)
PA MDSAP ISO 13485:2016, Certificate No. QS6 044904 0053, Ver 02, Exp 2025-08-001
pdf (453.4 KB)
B. Braun MDR Class I sterile – G11 044904 0056, Rev 00, Exp 2027-09-22
pdf (293.4 KB)
B. Braun MDR Class II – G10 044904 0057, Rev. 00, Exp 2027-09-22
pdf (293.6 KB)
DR EN ISO 13485:2016 Certificate No. QS6 040410 0007 Rev. 00 Exp. 2024-04-22
pdf (337.2 KB)
TX MDSAP ISO 13485:2016, Certificate No. QS6 045700 0005, Rev 04, Exp 2026-11-16
pdf (417.3 KB)
PA EN ISO 11135:2014 Supplement to QMS, Certificate No. SUP 044904 0055, Rev 00
pdf (201.7 KB)
B. Braun Medical, Inc. - EC Cert: Class I sterile # G2S 044904 0051, Rev 00
pdf (224.6 KB)
Korean KCL-BBAA-16415: B. Braun Dominican Republic, Exp 2026-02-01
pdf (390.5 KB)
Korean Certificate: KCL-BBAA-7508, B. Braun-901 Marcon, PA-Exp. 2024-08-03
pdf (83.3 KB)
B. Braun Medical, Inc. – EC Cert: Class IIa, IIb, III, # G1 044904 0052 Rev 00
pdf (125.1 KB)
B. Braun Medical, Inc., Dominical Republic - Japan FMA Certificate, No. BG32300005, Exp 25-09-2027
pdf (265.9 KB)
B. Braun Medical, Inc., Allentown, PA – Japan FMA Certificate, No. BG30400385, Exp 15-08-2027
pdf (258.0 KB)
Korean Certificate: KCL-BBA-19684, B. Braun – 12th Ave, PA-Exp. 2027-01-01
pdf (255.9 KB)

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