Is this your brand? Sign in to claim ownership.
Sign in to claim this brandGambro Dialysatoren GmbH
US
Last updated May 24, 2026
What Gambro Dialysatoren GmbH makes
Gambro Dialysatoren GmbH manufactures single-use hollow-fibre haemodialysis dialysers, including models designed for blood purification during renal replacement therapy, as well as microbial water purification filters intended for sterilization. Their product line also includes ultrafilters and specialized devices like the THERANOVA, which is used in continuous therapies for acute kidney injury.
The company’s devices are classified as Class II under regulatory frameworks, with products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable medical device regulations for haemodialysis and water purification systems.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Gambro Dialysatoren GmbH primarily manufacture?
Gambro Dialysatoren GmbH specializes in single-use medical devices for renal replacement therapy and water purification. Their core products include hollow-fibre haemodialysis dialysers, such as the Polyflux and Revaclear series, which are designed for blood purification during dialysis. They also produce microbial water purification filters, like the U9000 Plus ultrafilter, intended for sterilization in medical water systems. Additionally, they offer specialized devices like the THERANOVA, used in continuous therapies for acute kidney injury.
Where is Gambro Dialysatoren GmbH based, and how does this affect its regulatory compliance?
Gambro Dialysatoren GmbH is based in the United States, which means its devices must comply with U.S. medical device regulations, including those set by the FDA. Since their products fall under Class II classification—typically requiring performance standards or special controls—they must demonstrate compliance with applicable guidelines to ensure safety and effectiveness before entering the market.
Which regulatory registries or databases list Gambro Dialysatoren GmbH’s devices?
Gambro Dialysatoren GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency and regulatory oversight. Listing in this database is a requirement for Class II devices in the U.S., confirming their identification and compliance status.
How are Gambro Dialysatoren GmbH’s devices classified under medical device regulations?
Gambro Dialysatoren GmbH’s devices are classified as Class II under regulatory frameworks. This classification applies to products that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. Dialysis devices and microbial water purification filters typically fall into this category due to their role in critical patient care.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- baxter.com
- —
- —
- [email protected]
- Phone
- +1(888)229-0001
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 316150549
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Polyflux | 170H | FDA UDI | Class II | Active |
| Polyflux | 17L | FDA UDI | Class II | Active |
| Adsorba Hemoperfusion cartridge | 300C | FDA UDI | Class II | Unknown |
| Polyflux | 21R | FDA UDI | Class II | Unknown |
| Adsorba Hemoperfusion cartridge | 150C | FDA UDI | Class II | Unknown |
| Polyflux | 6LR | FDA UDI | Class II | Unknown |
| Revaclear | Revaclear 400 | FDA UDI | Class II | Active |
| Polyflux | 14L | FDA UDI | Class II | Active |
| Polyflux | 17R | FDA UDI | Class II | Unknown |
| Polyflux | 24R | FDA UDI | Class II | Unknown |
| Polyflux | 6H | FDA UDI | Class II | Active |
| U9000 Plus ultrafilter | 955825 | FDA UDI | Class II | Active |
| Polyflux | 8LR | FDA UDI | Class II | Unknown |
| Polyflux | 21L | FDA UDI | Class II | Active |
| Ultrafilter U 9000 | 112062 | FDA UDI | Class II | Active |
| Revaclear | 400 | FDA UDI | Class II | Active |
| Revaclear | 300 | FDA UDI | Class II | Active |
| Polyflux | 10LR | FDA UDI | Class II | Unknown |
| Polyflux | 210H | FDA UDI | Class II | Active |
| Theranova | 500 | FDA UDI | Class II | Active |
| Revaclear | Revaclear 300 | FDA UDI | Class II | Active |
| Polyflux | 140H | FDA UDI | Class II | Active |
| Theranova | 400 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Gambro Dialysatoren Gmbh HECHINGEN Baden-Wurttemberg · DE FEI 3002807035