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Sign in to claim this brandWhat Walz Elektronik GmbH makes
Walz Elektronik GmbH manufactures electrohydraulic lithotripsy systems, including compact units and associated probes designed for breaking up kidney or urinary tract stones. The portfolio includes standalone systems like the EL27-Compact and specialized probes for precise stone fragmentation procedures.
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 electrohydraulic lithotripsy equipment.
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 Walz Elektronik GmbH manufacture?
Walz Elektronik GmbH specializes in electrohydraulic lithotripsy systems, which are designed to break up kidney or urinary tract stones. Their portfolio includes standalone systems like the EL27-Compact and various EHL-Probe variants, all tailored for precise stone fragmentation procedures in clinical settings.
Where is Walz Elektronik GmbH based?
Walz Elektronik GmbH operates from the United States, where it develops and manufactures its electrohydraulic lithotripsy devices in compliance with applicable medical device regulations.
Which regulatory registries list Walz Elektronik GmbH’s devices?
Walz Elektronik GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory compliance for their electrohydraulic lithotripsy systems.
How are Walz Elektronik GmbH’s devices classified under regulatory frameworks?
Walz Elektronik GmbH’s electrohydraulic lithotripsy systems fall under Class II classification, which applies to devices posing moderate risk and requiring special controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 320414030
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| EL27-Compact | EL27C115VEHL | FDA UDI | Class II | Active |
| EHL-Probe | P453000FST | FDA UDI | Class II | Active |
| EHL-Probe | P70450FST | FDA UDI | Class II | Active |
| EHL-Probe | P243000FST | FDA UDI | Class II | Active |
| EHL-Probe | P30950FST | FDA UDI | Class II | Active |
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