Identity
- Trade Name
- MODULITH SLX-F2 EUDAMEDMODULITH® FDA UDI
- Generic Name
- Electromechanical lithotripsy system, extracorporeal FDA UDI
- Device Name
- MODULITH SLX-F2 EUDAMEDEquipment for the extracorporeal induced shock wave therapy for stationary and mobile use. FDA UDI
- Model / Reference
- 39000.0003 EUDAMEDSLX-F2 FDA UDI
- Description
- Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use. FDA UDI
Identifiers
- Catalog Number
- 39000.0003 FDA UDI
- Primary DI / UDI-DI
- 07630039101466 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300391ESWL002-QC EUDAMED
- Direct Marketing DI
- 07630039101466 EUDAMED
- 510(k) Number
- K201001 FDA UDI
- FDA Product Code
- LNS FDA UDI
- EMDN Code
- Z12160101 EXTRACORPOREAL LITHOTRIPTERS EUDAMED
- GMDN Term
- Electromechanical lithotripsy system, extracorporeal FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5990 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
Yes
FDA UDI
Modulith Slx-F2 by Storz Medical 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 | 76300391ESWL002-QC | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Storz Medical Ag
- EUDAMED SRN
- CH-MF-000014374
- Authorised Representative
- STORZ MEDICAL Deutschland GmbH DE-AR-000009017
Sources (2)
- EUDAMED 0a410286-f657-409d-85b3-3829e07685d5 61 fields · synced May 30, 2026
- FDA UDI ad05919c-f4a7-4b58-a638-d4b876cebff7 35 fields · synced May 30, 2026