FDA Registration
Active
🇩🇪 Germany
electrohydraulic Lithotriptor
Reg #: 1000161819
·
FEI: 1000161819
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- WALZ ELEKTRONIK GMBH
- Registration Number
- 1000161819
- FEI Number
- 1000161819
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Walddorfer Strasse 40
- City
- Rohrdorf Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K230488
Owner / Operator
- Firm Name
- Walz Elektronik GmbH
- Operator Number
- 10088634
- Address
- Walddorfer Strasse 40
- City
- Rohrdorf
- State
- Baden-Wurttemberg
- Postal Code
- 72229
- Country
- DE
- Correspondent
- Christian Schweizer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lithotriptor, Electro-Hydraulic | FFK | Class 2 | Gastroenterology, Urology | No | 2023-09-11 |
Proprietary Names
electrohydraulic Lithotriptor
sterile EHL-Probes
Establishment Types
Manufacture Medical Device