Identity
- Trade Name
- AQUAbase® EUDAMEDFDA UDI
- Generic Name
- Reverse-osmosis water purification system FDA UDI
- Device Name
- AQUAbase nX EUDAMEDAQUAbase® nX HT 500 Reverse Osmosis System FDA UDI
- Model / Reference
- LA1101351 EUDAMEDFDA UDI
- Description
- AQUAbase® nX HT 500 Reverse Osmosis System FDA UDI
Identifiers
- Catalog Number
- LA1101351 FDA UDI
- Primary DI / UDI-DI
- 04046955725168 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000019302U EUDAMED
- Direct Marketing DI
- 04046955725168 EUDAMED
- 510(k) Number
- K223479 FDA UDI
- FDA Product Code
- FIP FDA UDI
- EMDN Code
- Z12099007 DIALYSIS WATER TREATMENT SYSTEMS EUDAMED
- GMDN Term
- Reverse-osmosis water purification system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5665 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AQUAbase® by B.Braun Avitum AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40392390000019302U | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- B. Braun Avitum AG
- EUDAMED SRN
- DE-MF-000005127
Sources (2)
- EUDAMED 3cfde66f-fa9c-44e5-98a6-0c7b3cc8b604 61 fields · synced Jul 9, 2026
- FDA UDI 04358443-7bcb-4e21-91b8-adb4734d6f9e 37 fields · synced May 30, 2026