Identity
- Trade Name
- MODULITH SLK EUDAMEDMODULITH® FDA UDI
- Generic Name
- Electromechanical lithotripsy system, extracorporeal FDA UDI
- Device Name
- MODULITH SLK EUDAMEDEquipment for the extracorporeal induced shock wave therapy for stationary and mobile use. FDA UDI
- Model / Reference
- 30000 EUDAMEDSLK FDA UDI
- Description
- Equipment for the extracorporeal induced shock wave therapy for stationary and mobile use. FDA UDI
Identifiers
- Catalog Number
- 30000 FDA UDI
- Primary DI / UDI-DI
- 07630039100902 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07630039100902 EUDAMED
- 510(k) Number
- K120769 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
- Türkiye 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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 Slk by Storz Medical AG — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07630039100902 | 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 fbfd14eb-85eb-46b8-817a-cb72a9d34b21 61 fields · synced Jul 31, 2026
- FDA UDI f005dd50-1efd-4d94-be68-abaa05308565 35 fields · synced May 30, 2026