Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007007791

FEI Number

3007007791

Entity Name

B. BRAUN AVITUM AG

City/State/Country

MELSUNGEN Hesse, DE

Establishment Address

Schwarzenberger Weg 73-79, --, MELSUNGEN Hesse D-34212, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

B. BRAUN Avitum AG (Owner Number: 9057188)

Owner / Operator Contact Address

Schwarzenberger Weg 73-79, --, MELSUNGEN, DE-NOTA D-34212, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K124059

PMA Number

N/A

All Registered Proprietary Names

AQUAbase nX HT AQUAbase nX Aquaboss® EcoRO Dia I 700 HT Aquaboss® EcoRO Dia I 2800 Aquaboss® EcoRO Dia II 1400 HT Aquaboss® EcoRO Dia II 900 Aquaboss® EcoRO Dia II 2800 HT Aquaboss® EcoRO Dia II 1800 Aquaboss® EcoRO Dia I 2450 HT Aquaboss® EcoRO Dia II 1050 Aquaboss® EcoRO Dia II 900 HT Aquaboss® EcoRO Dia II 2100 Aquaboss® EcoRO Dia I 1400 Aquaboss® EcoRO Dia I 700 Aquaboss® EcoRO Dia I 2100 Aquaboss® EcoRO Dia I 3600 Aquaboss® EcoRO Dia II 1400 Aquaboss® EcoRO Dia II 1050 HT Aquaboss® EcoRO Dia I 1250 Aquaboss® EcoRO Dia I 3600 HT Aquaboss® EcoRO Dia II 700 HT Aquaboss® EcoRO Dia II 2100 HT Aquaboss® EcoRO Dia II 2800 Aquaboss® EcoRO Dia I 2450 Aquaboss® EcoRO Dia II 2450 Aquaboss® EcoRO Dia I 1050 Aquaboss® EcoRO Dia I 2100 HT Aquaboss® EcoRO Dia II 2450 HT Aquaboss® EcoRO Dia I 1800 HT Aquaboss® EcoRO Dia II 3600 Aquaboss® EcoRO Dia I 1400 HT Aquaboss® EcoRO Dia II 1800 HT Aquaboss® EcoRO Dia I 2800 HT Aquaboss® EcoRO Dia I 900 HT Aquaboss® EcoRO Dia I 1800 Aquaboss® EcoRO Dia I 1250 HT Aquaboss® EcoRO Dia II 700 Aquaboss® EcoRO Dia I 1050 HT Aquaboss® EcoRO Dia II 3600 HT Aquaboss® EcoRO Dia II 1250

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2023-09-07
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2020-01-30

Official Correspondent

Kamaal Anas

US Agent Details

Kamaal Anas Business: B. Braun Medical Inc. Email: kamaal.anas@bbraunusa.com Phone: (484) 5231349

Related Public Records

Same Entity

B. BRAUN Avitum AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9681240	B. Braun Avitum Italy S.p.A.	MIRANDOLA Modena, IT
3004201412	B. Braun Avitum Saxonia GmbH	RADEBERG Saxony, DE
3014300273	B.Braun Avitum Saxonia GmbH	Wilsdruff Saxony, DE
3002879653	B. Braun Avitum AG	MELSUNGEN Hesse, DE
3004176176	B. Braun Avitum AG	GLANDORF Lower Saxony, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K110578	Mar Cor Purification, Inc.	MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM	2011-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-05	Ameriwater Inc	2	AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

Similar Registrations

Registration Number	Establishment Name	Location
3010867648	NELSON ENVIRONMENTAL TECHNOLOGIES, INC.	Arlington, TX, US
2135346	CULLIGAN SOFT WATER SERVICE CO.	Minnetonka, MN, US
3015349756	DIALITY, INC.	Irvine, CA, US
3003550196	Veolia Water Treatment & Solutions	ARLINGTON, TX, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007007791. Last updated year: 2026. Please use registration number 3007007791 when referencing this establishment in official correspondence.