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GMP Compliance

Providing quality products and services for over 40 years

B. Braun acknowledges that to be truly competitive in today’s market, we must have a quality system that governs all phases of business operations to guarantee our customers will consistently receive the quality products and service 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; Medical Devices Regulations (EU) 2017/745; the Medical Device Directives 93/42/EEC and 2007/47/EC (MDD); MHLW/PMDA and the Canadian Medical Device Regulations and is conducive to continuous improvement in all aspects of the company.

Related Documents

PA EN ISO 13485:2016, Certificate No Q5 044904 0046, Rev 03, Exp 2027-09-04

pdf, 341.5 KB

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PA MDSAP ISO 13485:2016, Certificate No. QS6 044904 0053, Rev 03, Exp 2025-08-01

pdf, 421.7 KB

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PA MDSAP ISO 13485:2016, Certificate No. QS6 044904 0053, Rev 04, Exp 2027-09-17

pdf, 421.7 KB

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B. Braun MDR Class I sterile – G11 044904 0056, Rev 00, Exp 2027-09-22

pdf, 273.9 KB

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B. Braun MDR Class II – G10 044904 0057, Rev. 00, Exp 2027-09-22

pdf, 274.2 KB

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DR EN ISO 134858:2016, Certificate No. QS6 040410 0007 Rev. 01 Exp 2027-04-21

pdf, 394.7 KB

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TX MDSAP ISO 13485:2016, Certificate No. QS6 045700 0005, Rev 05, Exp 2026-11-16

pdf, 417.4 KB

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PA EN ISO 11135:2014+A1:2019 Supplement Certificate No 44904 0055, Rev 02

pdf, 226.8 KB

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Korean KCL-BBAA-16415: B. Braun Dominican Republic, Exp 2026-02-01

pdf, 390.5 KB

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Korean Certificate: KCL-BBAA-20543, B. Braun US Device Manufacturing LLC, PA – Exp. 2027-05-06

pdf, 93.9 KB

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B. Braun Medical Inc., Dominican Republic - Japan FMA Certificate, No. BG32300005, Exp 25-09-2027

pdf, 265.9 KB

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B. Braun Medical Inc. and B. Braun US Device Manufacturing LLC – Japan FMA Certificate, No. BG30403747, Exp 12-10-2028

pdf, 253.1 KB

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Korean Certificate: KCL-BBAA-19384, B. Braun – 12th Ave, PA-Exp. 2027-01-01

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Taiwan Certificate: QSD1597, B. Braun US Device Manufacturing LLC – 901 Marcon, PA – Exp 2027-10-28

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B Braun Medical Inc - EU MDR 2023-607 Confirmation Letter 044904 0058 Rev 02

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Accreditations

VAWD Accredited Wholesale Distribution Facility

Visit the VAWD website for more information.